A yeast fermentate improves gastrointestinal discomfort and constipation by modulation of the gut microbiome: results from a randomized double-blind placebo-controlled pilot trial

Study information

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study design

randomized controlled trial

Citation

PMID PubMed identifier for scientific articles.

28870194

DOI Digital object identifier for electronic documents.

10.1186/s12906-017-1948-0

URI Uniform resource identifier for web resources.

Authors

Pinheiro I, Robinson L, Verhelst A, Marzorati M, Winkens B, den Abbeele PV, Possemiers S

Journal

BMC complementary and alternative medicine

Year

2017

Keywords:

Bacteroides, Bacteroidetes, Constipation, EpiCor fermentate, GI transit time, Gastrointestinal discomfort, Gut microbiome, Human study, Prevotella, Saccharomyces cerevisiae

BACKGROUND: Constipation and symptoms of gastrointestinal discomfort such as bloating are common among otherwise healthy individuals, but with significant impact on quality of life. Despite the recognized contribution of the gut microbiome to this pathology, little is known about which group(s) of microorganism(s) are playing a role. A previous study performed in vitro suggests that EpiCor® fermentate has prebiotic-like properties, being able to favorably modulate the composition of the gut microbiome. Therefore, the aim of this study was to investigate the effects of EpiCor fermentate in a population with symptoms of gastrointestinal discomfort and reduced bowel movements and to evaluate its effect at the level of the gut microbiome. METHODS: This pilot study was performed according to a randomized, double-blind, placebo-controlled parallel design. Eighty subjects with symptoms of gastrointestinal discomfort and constipation were allocated to one of two trial arms (placebo or EpiCor fermentate). Randomization was done in a stratified manner according to symptom severity, resulting in two subgroups of patients: severe and moderate. Daily records of gastrointestinal symptoms were assessed on a 5-point scale, and also stool frequency and consistency were documented during a 2-week run-in and a 6-week intervention phases. Averages over two-week intervals were calculated. Constipation-associated quality of life and general perceived stress were assessed at baseline and after 3 and 6 weeks of intervention. Fecal samples were also collected at these same time points. RESULTS: EpiCor fermentate led to a significant improvement of symptoms such as bloating/distension (p = 0.033 and p = 0.024 after 2 and 4 weeks of intervention, respectively), feeling of fullness (p = 0.004 and p = 0.023 after 2 and 4 weeks of intervention, respectively) and general daily scores (p = 0.046 after 2 weeks of intervention) in the moderate subgroup. A significant improvement in stool consistency was observed for the total population (p = 0.023 after 2 weeks of intervention) as well as for the severe subgroup (p = 0.046 after 2 weeks of intervention), and a nearly significant increase in stool frequency was detected for the total cohort (p = 0.083 and p = 0.090 after 2 and 4 weeks of intervention, respectively). These effects were accompanied by an improvement in constipation-associated quality of life and general perceived stress, particularly in the moderate subgroup. Members of the families Bacteroidaceae and Prevotellaceae, two groups of bacteria that have been previously reported to be deficient in constipated patients, were found to increase with EpiCor fermentate in the severe subgroup. In the moderate subgroup, a significant increase in Akkermansia muciniphila was observed. CONCLUSIONS: Despite the relatively low dose administered (500 mg/day), particularly when comparing to the high recommended doses for prebiotic fibers, EpiCor fermentate was able to modulate the composition of the gut microbiome, resulting in improvement of constipation-associated symptoms. Conversely, the reported increase in bowel movements may have altered the gut microbial community by increasing those groups of bacteria that are better adapted to a faster gastrointestinal transit time. TRIAL REGISTRATION: NCT03051399 at ClinicalTrials.gov. Retrospectively registered. Registration date: 13 February 2017.

Experiment 1

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Curated date: 2025/03/19

Curator: Munaa

Revision editor(s): Munaa, Tosin, Anne-mariesharp

Subjects

Location of subjects

Belgium

Host species Species from which microbiome was sampled. Contact us to have more species added.

Homo sapiens

Body site Anatomical site where microbial samples were extracted from according to the Uber Anatomy Ontology

Feces Cow dung,Cow pat,Droppings,Dung,Excrement,Excreta,Faeces,Fecal material,Fecal matter,Fewmet,Frass,Guano,Matières fécales@fr,Merde@fr,Ordure,Partie de la merde@fr,Piece of shit,Porción de mierda@es,Portion of dung,Portion of excrement,Portion of faeces,Portion of fecal material,Portion of fecal matter,Portion of feces,Portion of guano,Portion of scat,Portionem cacas,Scat,Spoor,Spraint,Stool,Teil der fäkalien@de,Feces,feces

Condition The experimental condition / phenotype studied according to the Experimental Factor Ontology

Chronic constipation Chronic constipation,Infrequent bowel movements,chronic constipation

Group 0 name Corresponds to the control (unexposed) group for case-control studies

Placebo Total cohort V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo Total cohort V2(Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

Participants in total cohort at visit 2 (3-weeks after treatment) who received the corresponding testing product (placebo)

Group 0 sample size Number of subjects in the control (unexposed) group

40

Group 1 sample size Number of subjects in the case (exposed) group

40

Antibiotics exclusion Number of days without antibiotics usage (if applicable) and other antibiotics-related criteria used to exclude participants (if any)

2 months

Lab analysis

Sequencing type

16S

16S variable region One or more hypervariable region(s) of the bacterial 16S gene

V5-V6

Sequencing platform Manufacturer and experimental platform used for quantifying microbial abundance

Illumina

Statistical Analysis

Data transformation Data transformation applied to microbial abundance measurements prior to differential abundance testing (if any).

relative abundances

Statistical test

ANOVA

Significance threshold p-value or FDR threshold used for differential abundance testing (if any)

0.1

MHT correction Have statistical tests be corrected for multiple hypothesis testing (MHT)?

No

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Source: Additional file 7

Description: Microbial taxa fold-changes (V2/V1) in Placebo total cohort.

Abundance in Group 1: increased abundance in Placebo Total cohort V2(Visit 2)

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Blautia
Dialister
Lachnospiraceae
Veillonellaceae

Revision editor(s): Munaa, Tosin, Anne-mariesharp

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Source: Additional file 7

Description: Microbial taxa fold-changes (V2/V1) in Placebo total cohort.

Abundance in Group 1: decreased abundance in Placebo Total cohort V2(Visit 2)

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Faecalibacterium
Oscillospiraceae
Parabacteroides
Porphyromonadaceae
unclassified Lachnospiraceae

Revision editor(s): Anne-mariesharp

Experiment 2

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

Placebo moderate subgroup V1 (Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo moderate subgroup V2 (Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with moderate symptoms of gastrointestinal discomfort and constipation at visit 2 (3-weeks after treatment) who received the corresponding testing product (placebo)

Group 0 sample size Number of subjects in the control (unexposed) group

13

Group 1 sample size Number of subjects in the case (exposed) group

13

Lab analysis

Statistical Analysis

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Source: Additional file 9

Description: Microbial taxa fold-changes (V2/V1) in Placebo moderate subgroup

Abundance in Group 1: increased abundance in Placebo moderate subgroup V2 (Visit 2)

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Bacteroidaceae
Bacteroides
Lachnospiraceae
Roseburia

Revision editor(s): Munaa, Tosin

Signature 2

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Source: Additional file 9

Description: Microbial taxa fold-changes (V2/V1) in Placebo moderate subgroup

Abundance in Group 1: decreased abundance in Placebo moderate subgroup V2 (Visit 2)

NCBI	Quality Control	Links
Barnesiella
Faecalibacterium
Oscillospiraceae
Parabacteroides
Porphyromonadaceae
unclassified Lachnospiraceae

Revision editor(s): Munaa, Tosin

Experiment 3

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Curator: Anne-mariesharp

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

Placebo Total cohort V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo Total cohort V3(Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

Participants in total cohort at visit 3 (6-weeks after treatment) who received the corresponding testing product (placebo)

Group 0 sample size Number of subjects in the control (unexposed) group

40

Group 1 sample size Number of subjects in the case (exposed) group

40

Lab analysis

Statistical Analysis

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Source: Additional file 7

Description: Microbial taxa fold-changes (V3/V1) in Placebo total cohort.

Abundance in Group 1: increased abundance in Placebo Total cohort V3(Visit 3)

NCBI	Quality Control	Links
Acidaminococcaceae
Blautia

Revision editor(s): Anne-mariesharp

Signature 2

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Source: Additional file 7

Description: Microbial taxa fold-changes (V3/V1) in Placebo total cohort

Abundance in Group 1: decreased abundance in Placebo Total cohort V3(Visit 3)

NCBI	Quality Control	Links
Faecalibacterium
Oscillospiraceae
Porphyromonadaceae

Revision editor(s): Anne-mariesharp

Experiment 4

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

EpiCor Total cohort V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Total cohort V2(Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

Participants in total cohort at visit 2 (3-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Group 0 sample size Number of subjects in the control (unexposed) group

39

Group 1 sample size Number of subjects in the case (exposed) group

39

Lab analysis

Statistical Analysis

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Source: Additional file 7

Description: Microbial taxa fold-changes (V2/V1) in EpiCor total cohort.

Abundance in Group 1: increased abundance in EpiCor Total cohort V2(Visit 2)

NCBI	Quality Control	Links
Anaerostipes
Prevotella

Revision editor(s): Anne-mariesharp

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Source: Additional file 7

Description: Microbial taxa fold-changes (V2/V1) in EpiCor total cohort

Abundance in Group 1: decreased abundance in EpiCor Total cohort V2(Visit 2)

NCBI	Quality Control	Links
Alistipes
Rikenellaceae
unclassified Bacillota

Revision editor(s): Anne-mariesharp

Experiment 5

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Differences from previous experiment shown

Subjects

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Total cohort V3(Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

Participants in total cohort at visit 3(6-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Lab analysis

Statistical Analysis

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Source: Additional file 7

Description: Microbial taxa fold-changes (V3/V1) in EpiCor total cohort

Abundance in Group 1: increased abundance in EpiCor Total cohort V3(Visit 3)

NCBI	Quality Control	Links
Anaerostipes
Bacteroides
Lachnospiraceae
unclassified Coriobacteriaceae
unclassified Lachnospiraceae

Revision editor(s): Anne-mariesharp

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Source: Additional file 7

Description: Microbial taxa fold-changes (V3/V1) in EpiCor total cohort

Abundance in Group 1: decreased abundance in EpiCor Total cohort V3(Visit 3)

NCBI	Quality Control	Links
unclassified Bacillota
Coprococcus
Oscillospiraceae
Faecalibacterium
unclassified Oscillospiraceae

Revision editor(s): Anne-mariesharp

Experiment 6

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

Placebo Severe subgroup V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo Severe subgroup V2(Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with severe symptoms of gastrointestinal discomfort and constipation at visit 2 (3-weeks after treatment) who received the corresponding testing product (Placebo)

Group 0 sample size Number of subjects in the control (unexposed) group

27

Group 1 sample size Number of subjects in the case (exposed) group

27

Lab analysis

Statistical Analysis

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Source: Additional file 8

Description: Microbial taxa fold-changes (V2/V1) in Severe subgroup (Placebo)

Abundance in Group 1: increased abundance in Placebo Severe subgroup V2(Visit 2)

NCBI	Quality Control	Links
Acidaminococcaceae
Lachnospiraceae
Blautia
Veillonellaceae
Dialister

Revision editor(s): Anne-mariesharp

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Source: Additional file 8

Description: Microbial taxa fold-changes (V2/V1) in Severe subgroup (Placebo)

Abundance in Group 1: decreased abundance in Placebo Severe subgroup V2(Visit 2)

NCBI	Quality Control	Links
Bacteroidaceae
Bacteroides
Bifidobacterium
Faecalibacterium
Oscillospiraceae

Revision editor(s): Anne-mariesharp

Experiment 7

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Differences from previous experiment shown

Subjects

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo Severe subgroup V3(Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A sub group of participants with severe symptoms of gastrointestinal discomfort and constipation at visit 3 (6-weeks after treatment) who received the corresponding testing product (Placebo)

Lab analysis

Statistical Analysis

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Source: Additional file 8

Description: Microbial taxa fold-changes (V3/V1) in Severe subgroup (Placebo)

Abundance in Group 1: increased abundance in Placebo Severe subgroup V3(Visit 3)

NCBI	Quality Control	Links
Acidaminococcaceae
Acidaminococcus
Blautia
Ruminococcus
Dialister

Revision editor(s): Anne-mariesharp

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Source: Additional file 8

Description: Microbial taxa fold-changes (V3/V1) in Severe subgroup (Placebo)

Abundance in Group 1: decreased abundance in Placebo Severe subgroup V3(Visit 3)

NCBI	Quality Control	Links
Alistipes
Bacteroides
Faecalibacterium
Oscillospiraceae
Roseburia

Revision editor(s): Anne-mariesharp

Experiment 8

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

EpiCor Severe subgroup V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Severe subgroup V2(Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with severe symptoms of gastrointestinal discomfort and constipation at visit 2 (3-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Lab analysis

Statistical Analysis

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Source: Additional file 8

Description: Microbial taxa fold-changes (V2/V1) in Severe subgroup (EpiCor)

Abundance in Group 1: increased abundance in EpiCor Severe subgroup V2(Visit 2)

NCBI	Quality Control	Links
Bacteroides
Prevotella
Anaerostipes

Revision editor(s): Anne-mariesharp

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Source: Additional file 8

Description: Microbial taxa fold-changes (V2/V1) in Severe subgroup (EpiCor)

Abundance in Group 1: decreased abundance in EpiCor Severe subgroup V2(Visit 2)

NCBI	Quality Control	Links
Alistipes
Faecalibacterium
Oscillospiraceae
Rikenellaceae

Revision editor(s): Anne-mariesharp

Experiment 9

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Differences from previous experiment shown

Subjects

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Severe subgroup V3 (Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A sub group of participants with severe symptoms of gastrointestinal discomfort and constipation at visit 3 (6-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Lab analysis

Statistical Analysis

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Source: Additional file 8

Description: Microbial taxa fold-changes (V3/V1) in Severe subgroup (EpiCor)

Abundance in Group 1: increased abundance in EpiCor Severe subgroup V3 (Visit 3)

NCBI	Quality Control	Links
Bacteroides
Lachnospiraceae
Anaerostipes
Roseburia

Revision editor(s): Anne-mariesharp

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Source: Additional file 8

Description: Microbial taxa fold-changes (V3/V1) in Severe subgroup (EpiCor)

Abundance in Group 1: decreased abundance in EpiCor Severe subgroup V3 (Visit 3)

NCBI	Quality Control	Links
Alistipes
Faecalibacterium
Oscillospiraceae
unclassified Bacillota

Revision editor(s): Anne-mariesharp

Experiment 10

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Curator: Tosin

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

Placebo moderate subgroup V1 (Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

Placebo moderate subgroup V3 (Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with moderate symptoms of gastrointestinal discomfort and constipation at visit 3 (6-weeks after treatment) who received the corresponding testing product (placebo)

Group 0 sample size Number of subjects in the control (unexposed) group

13

Group 1 sample size Number of subjects in the case (exposed) group

13

Lab analysis

Statistical Analysis

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Source: Additional file 9

Description: Microbial taxa fold-changes (V3/V1) in Placebo moderate subgroup

Abundance in Group 1: increased abundance in Placebo moderate subgroup V3 (Visit 3)

NCBI	Quality Control	Links
Anaerostipes
Bacteroidaceae
Bacteroides
Lachnospiraceae
Roseburia

Revision editor(s): Tosin

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Source: Additional file 9

Description: Microbial taxa fold-changes (V3/V1) in Placebo moderate subgroup

Abundance in Group 1: decreased abundance in Placebo moderate subgroup V3 (Visit 3)

NCBI	Quality Control	Links
Barnesiella
Oscillospiraceae
Parabacteroides
Porphyromonadaceae
unclassified Oscillospiraceae

Revision editor(s): Tosin

Experiment 11

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Differences from previous experiment shown

Subjects

Group 0 name Corresponds to the control (unexposed) group for case-control studies

EpiCor Moderate subgroup V1(Visit 1)

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Moderate subgroup V2(Visit 2)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with moderate symptoms of gastrointestinal discomfort and constipation at visit 2 (3-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Group 0 sample size Number of subjects in the control (unexposed) group

12

Group 1 sample size Number of subjects in the case (exposed) group

12

Lab analysis

Statistical Analysis

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Source: Additional file 9

Description: Microbial taxa fold-changes (V2/V1) in Epicor moderate subgroup

Abundance in Group 1: increased abundance in EpiCor Moderate subgroup V2(Visit 2)

NCBI	Quality Control	Links
Akkermansia
Oscillospiraceae
Sutterella
unclassified Lachnospiraceae

Revision editor(s): Tosin

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Source: Additional file 9

Description: Microbial taxa fold-changes (V2/V1) in Epicor moderate subgroup

Abundance in Group 1: decreased abundance in EpiCor Moderate subgroup V2(Visit 2)

NCBI	Quality Control	Links
Bacteroides
Bifidobacterium
Blautia
Lachnospiraceae
Roseburia
Ruminococcus

Revision editor(s): Tosin

Experiment 12

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Curator: Tosin

Revision editor(s): Tosin, Anne-mariesharp

Differences from previous experiment shown

Subjects

Group 1 name Corresponds to the case (exposed) group for case-control studies

EpiCor Moderate subgroup V3(Visit 3)

Group 1 definition Diagnostic criteria applied to define the specific condition / phenotype represented in the case (exposed) group

A subgroup of participants with moderate symptoms of gastrointestinal discomfort and constipation at visit 3 (6-weeks after treatment) who received the corresponding testing product (EpiCor fermentate)

Lab analysis

Statistical Analysis

Signature 1

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Reviewed Marked as Reviewed by Svetlana up on 2025-4-23

Curated date: 2025/04/21

Curator: Tosin

Revision editor(s): Tosin

Source: Additional file 9

Description: Microbial taxa fold-changes (V3/V1) in Epicor moderate subgroup

Abundance in Group 1: increased abundance in EpiCor Moderate subgroup V3(Visit 3)

NCBI	Quality Control	Links
Akkermansia
unclassified Coriobacteriaceae
unclassified Lachnospiraceae

Revision editor(s): Tosin

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Your review change was submitted

Reviewed Marked as Reviewed by Svetlana up on 2025-4-23

Curated date: 2025/04/21

Curator: Tosin

Revision editor(s): Tosin

Source: Additional file 9

Description: Microbial taxa fold-changes (V3/V1) in Epicor moderate subgroup

Abundance in Group 1: decreased abundance in EpiCor Moderate subgroup V3(Visit 3)

NCBI	Quality Control	Links
Blautia
Coprococcus
Lachnospiraceae
Roseburia
unclassified Oscillospiraceae

Revision editor(s): Tosin