The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight (myBIOM)

The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight: a Randomized, Double-blind, Placebo-controlled Study

The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.

The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Symptoms; Gastrointestinal Microbiome (Focus)
• Intervention / Treatment: Dietary supplement: Synbiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Engel, PhD; Phone Number: +45 45 74 74 74; Email: saen@novonesis.com
• Study Contact Backup: Name: Emma Harrington; Email: eharrington@atlantiatrials.com

Study Locations

• Ireland
  • Blackpool
    • Cork, Blackpool, Ireland, T23 R50R
      • Recruiting
      • Atlantia Clinical Trials Ltd
      • Contact: Emma Harrington; Phone Number: +353 (0)21 430 7442; Email: eharrington@atlantiatrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Be able to give informed consent.
2. Be between 50 to 70 years of age (inclusive).
3. BMI ranging from 25.0 and 35.0 kg/m²
4. Willing to maintain current level of physical activity and diet during the participation in the study.
5. Experience ≤3 bowel movements per week within the month prior to screening
6. Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening.
7. Willing to consume the study product daily for the duration of the study.
8. Willing to eat the same meal the evening before visiting site (visit 2 to visit 5).

Participants are eligible for randomization if they fulfill the following two criteria based on the diary recordings during the run-in period prior to visit 2 9. Average GSRS-IBS composite symptom score between 20-45 during the two-week run-in period Record ≤6 bowel movements in the daily diary during the two-week run-in period

Exclusion Criteria:

1. Has a history of drug and/or alcohol abuse.
2. Has food allergies, or other issues with foods, that would preclude intake of the study products.
3. Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.

4. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:

   1. diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)
   2. GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time.
   3. history of CVD
   4. uncontrolled hypertension

5. Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

   1. systemic antimicrobial medication (including suppositories) within 4 weeks prior to visit 1
   2. OTC medications, for digestive symptoms such as PPIs, anti-spasmodics, laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1

10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.

11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.

c. immunosuppressant drugs within the 4 weeks prior to the visit 1 d. systemic steroids within the 4 weeks prior to the visit 1 6. Regular oral non-steroidal anti-inflammatory (NSAIDs) within 1 week prior to visit 1 (topical NSAIDS allowed, Low-dose prophylactic aspirin use is acceptable if stable for 3 months prior to screening.) 7. Current or recent (in the past 4 weeks prior to visit 1) use of prohibited nutritional and non-nutritional supplements, that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, including:

a. Herbal supplements for digestive symptoms b. Large doses of vitamins and minerals, unless in stable dose c. Probiotic supplements d. Iron supplements 8. Current or recent (in the past 2-weeks) use of prohibited foods including yoghurts containing probiotics.

9. Planned major changes in lifestyle [i.e., diet (e.g. start of fibre-enriched diet), dieting, exercise level, travelling] during the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Identical looking placebo consisting of maltodextrin	Dietary supplement: Placebo; Placebo - Given daily for 56 days
Active Comparator: Synbiotic; Synbiotic dietary supplement	Dietary supplement: Synbiotic; Synbiotic - Given daily for 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bifidobacterium abundance	Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing.	From baseline to end of intervention at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool frequency	Change in number of daily bowel movements from 2 weeks average prior to baseline to 2 weeks average prior to end of intervention. An increase is desirable.	From baseline to end of intervention at 8 weeks
Fecal acetate	Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.	From baseline to end of intervention at 8 weeks.
Fecal propionate	Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.	From baseline to end of intervention at 8 weeks.
Fecal butyrate	Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.	From baseline to end of intervention at 8 weeks
Zonulin	Change in serum zonulin from baseline to 8 weeks	From baseline to end of intervention at 8 weeks
Lipopolysaccharide binding protein (LPS-BP)	Change in plasma LPS-BP from baseline to 8 weeks	From baseline to end of intervention at 8 weeks
Interleukin 6 (IL-6)	Change in serum IL-6 from baseline to 8 weeks	From baseline to end of intervention at 8 weeks
High-sensitivity C-Reactive Protein (hsCRP)	Change in serum hsCRP from baseline to 8 weeks.	From baseline to end of intervention at 8 weeks
Fecal Short-Chain Fatty Acids (SCFA)	Change in composite measurement of fecal SCFAs panel with targeted metabolomics (GC-MSMS) from baseline to 8 weeks. Total composite is defined as: acetate + propionate + butyrate.	From baseline to end of intervention at 8 weeks
Stool consistency	Change in mean stool consistency assessed daily from 2 weeks prior to baseline to daily 2 weeks prior to end-of intervention. Stool consistency will be assessed by Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces). An increase in stool consistency is desirable.	From baseline to end of intervention at 8 weeks
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score	Change in GSRS-IBS composite score from baseline to end-of-intervention visit. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable.	From baseline to end of intervention at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of probiotic strains	Recovery and colonization of strains by strain specific qPCR of fecal samples	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
Total relative abundance of Bifidobacterium	Change in total relative abundance of Bifidobacterium after 2 weeks of follow-up (no intervention) compared to effect after 3 weeks and 8 weeks of intervention.	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up.
Microbiome composition and taxonomic profiles	Changes in gut microbiome composition and taxonomic profiling analyzed by shotgun metagenomic sequencing of fecal samples	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
Microbiome functional profiling	Change in gut microbiome functional profiling analyzed by shotgun metagenomic sequencing of fecal samples	Basline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
Plasma Metabolomics	Change in blood metabolome as assessed by untargeted and targeted metabolomics from plasma samples	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
Fecal metabolomics	Change in fecal metabolome as assessed by untargeted and targeted metabolomics from fecal samples	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
Bacterial HMO utilization genes	Abundance development over time of HMO degradation and modification genes such as Glycosyl hydrolases, encoded by probiotic supplements and endogenous gut species	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
HMO concentration in blood and feces	Change in HMO in plasma and fecal samples after 3 and 8 weeks of supplementation	Baseline, 3 weeks and end of intervention at 8 weeks
Fecal pH	Change in pH assessed using a pH meter in fecal samples	Baseline, 3 weeks and end of intervention at 8 weeks
Inflammatory Biomarkers	Change in inflammatory biomarkers measured in serum	Baseline, 3 weeks and end of intervention at 8 weeks
Cardiometabolic Biomarkers	Change in cardiometabolic biomarkers	Baseline, 3 weeks and end of intervention at 8 weeks
Cognitive function measured by the Trails Making Test (Parts A & B)	Change in cognitive function assessed using Trail Making Test (Parts A & B)	Baseline and end of intervention at 8 weeks
Cognitive function measured by the Stroop Colour and Word Test	Change in cognitive function assessed using the Stroop Colour and Word Test	Baseline and end of intervention at 8 weeks
Cognitive function measured by the Symbol Digit Modalities Test (SDMT)	Change in cognitive function assessed using the Symbol Digit Modalities Test (SDMT)	Baseline and end of intervention at 8 weeks
Health-related Quality of Life	Change in health-related quality of life assessed by Short Form-36 (RAND SF-36)	Baseline, 3 weeks and end of intervention at 8 weeks
Gastrointestinal Symptoms Measured by the GSRS-IBS Total Score	Change in gastrointestinal symptoms by assessing the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS). The outcome reflects the total composite score. A decrease is desirable.	Baseline, 3 weeks, 8 weeks (end of intervention) and 2 weeks of follow-up
GSRS-IBS Pain Subscale	Change in the gastrointestinal symptom pain assessed using GSRS-IBS subscale for Pain. A decrease is desirable.	Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up.
GSRS-IBS Bloating Subscale	Change in the gastrointestinal symptom bloating assessed using GSRS-IBS subscale for bloating. A decrease is desirable.	Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up
GSRS-IBS Constipation Subscale	Change in the gastrointestinal symptom constipation assessed using GSRS-IBS subscale for constipation. A decrease is desirable	Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up
GSRS-IBS Diarrhea Subscale	Change in the gastrointestinal symptom Diarrhea assessed using GSRS-IBS subscale for Diarrhea. A decrease is desirable.	Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up
GSRS-IBS Early Satiety Subscale	Change in the gastrointestinal symptom early satiety assessed using GSRS-IBS subscale for early satiety.	Baseline, 3 weeks, 8 weeks, and 2 weeks of follow-up
Protein Composite Score	Change in protein composite score measured using OLINK Reveal panel	Baseline, 3 weeks and end of intervention at 8 weeks

Collaborators and Investigators

• Sponsor: Chr Hansen - part of Novonesis
• Investigators: Principal Investigator: Timothy G Dinan, Professor, Atlantia Clinical Trials Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gastrointestinal Microbiome; Synbiotic
• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Prebiotics; Probiotics; Synbiotics
• Other Study ID Numbers: HHB-GI-2406; ECM4(i)11/12/2025 (Other Identifier: Clinical Research Ethics Committee of the Cork Teaching Hospitals)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No