Dietary supplements to improve gut health in IBS-D patients

Pilot Study - the Effect of Bioactive Compounds N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Intestinal Barrier Function in Participants with Irritable Bowel Syndrom with Diarrhoea

This study tests whether two natural supplements can help improve gut health and symptoms for people with Irritable Bowel Syndrome with Diarrhea (IBS-D).

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Functional Gut Clinic (Academic / other)
• Locations: 2 sites (London and 1 other locations)
• Trial ID: NCT06543498 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of two natural compounds on intestinal barrier function in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). Participants will receive either the active compounds or a placebo, and their gut health will be assessed through various tests and questionnaires. The goal is to determine if these dietary supplements can effectively improve symptoms and quality of life for those suffering from IBS-D. The study aims to provide a safe and non-pharmacological treatment option for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of IBS-D and specific severity scores.

Not a fit: Patients with IBS types other than IBS-D or those with severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new, effective treatment option for patients suffering from IBS-D.

How similar studies have performed: While there is ongoing research into dietary interventions for IBS, this specific combination of compounds is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
2. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria, confirmed by bowel diary.
3. Participant has an IBS-SSS score of \>175
4. LPS at screening \>0.21 ng/ml.
5. Participant is a male or non-pregnant female and is 18-70 years of age
6. If WOCBP participant is willing to adhere to one of the following methods of contraception i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) iv) Hysterectomy v) Vasectomised partner vi) Sexual abstinence (if it is in line with your preferred and usual lifestyle).
7. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
8. Participant has capacity to understand written English.
9. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
10. Participant agrees to follow all pre-test preparation before L/M testing.

Exclusion Criteria:

1. Prior abdominal surgery other than appendectomy, tubal ligation, hysterectomy or cholecystectomy.
2. Participated in a trial of an investigational medical product or medical device in the last 28 days.
3. Females who report to be pregnant or lactating
4. Unwilling to maintain stable doses of permitted concomitant medication.
5. Unwilling to maintain a stable diet for the duration of the trial.
6. Being in the opinion of the investigator unsuitable
7. Insufficient knowledge of English to complete the daily bowel diary and food diary.
8. Hypersensitivity to any component of the supplement
9. Hypersensitivity or known allergy to lactulose or mannitol.
10. Consumption of oral antibiotics in the last 2 weeks.
11. NSAIDs for 2 weeks prior to and during the entire 21 day study period. Participant should not be a chronic NSAID user (\>1 day/week).
12. Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
13. Diabetes mellitus (type 1).
14. Participants with known hepatic disease.
15. Inflammatory bowel disease (Crohn's/Colitis) or coeliac disease.
16. Gastrointestinal infection in the past 4 weeks.
17. Any other condition, deemed by the investigator, that may be causing their symptoms.
18. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
19. Participant is unable to adhere to withholding in endurance exercise, such as \>45 minutes of high intensity running, cycling, rowing etc, from the screening phone call to the end of study visit.

Where this trial is running

London and 1 other locations

• The Functional Gut Clinic — London, United Kingdom (Recruiting)
• The Functional Gut Clinic — Manchester, United Kingdom (Recruiting)

Conditions Irritable Bowel Syndrome with Diarrhea