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

Last updated: April 14, 2026
Sponsor: Chr Hansen - part of Novonesis
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-ulcer Dyspepsia (Nud)

Treatment

Synbiotic

Placebo

Clinical Study ID

NCT07453823
HHB-GI-2406
ECM4(i)11/12/2025
  • Ages 50-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 theparticipation 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 asdefined 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

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 thestudy 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 preventthem from fulfilling the study requirements, put the Participant at risk or wouldconfound the interpretation of the study results as judged by the investigator onthe basis of medical history and routine laboratory test results. Excluded healthconditions include:

  5. diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory boweldisease, colon cancer) or irritable bowel syndrome (IBS)

  6. GI surgery that might have an effect on gastrointestinal tract function exceptcholecystectomy and appendectomy in the past 5 years or any major bowelresection at any time.

  7. history of CVD

  8. uncontrolled hypertension

  9. Currently or recently taking a medication that the investigator believes wouldinterfere with the objectives of the study or pose a safety risk or confound theinterpretation of the study results. Prohibited medications include:

  10. systemic antimicrobial medication (including suppositories) within 4 weeksprior to visit 1

  11. OTC medications, for digestive symptoms such as PPIs, anti-spasmodics,laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1

  12. 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.

  13. 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.

  1. 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 Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Synbiotic
Phase:
Study Start date:
March 18, 2026
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Atlantia Clinical Trials Ltd

    Cork, Blackpool T23 R50R
    Ireland

    Active - Recruiting

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