Status:
COMPLETED
The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D
Lead Sponsor:
Dr Anthony Hobson
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Many people suffer from Irritable Bowel Syndrome (IBS) every year in the UK. Depending on the stool consistency, IBS can be classified as IBS with diarrhoea (IBS-D), IBS with constipation (IBS-C), or ...
Eligibility Criteria
Inclusion
- 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.
- Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria, confirmed by bowel diary.
- Participant has an IBS-SSS score of \>175
- LPS at screening \>0.21 ng/ml.
- Participant is a male or non-pregnant female and is 18-70 years of age
- 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).
- Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
- Participant has capacity to understand written English.
- Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
- Participant agrees to follow all pre-test preparation before L/M testing.
Exclusion
- Prior abdominal surgery other than appendectomy, tubal ligation, hysterectomy or cholecystectomy.
- Participated in a trial of an investigational medical product or medical device in the last 28 days.
- Females who report to be pregnant or lactating
- Unwilling to maintain stable doses of permitted concomitant medication.
- Unwilling to maintain a stable diet for the duration of the trial.
- Being in the opinion of the investigator unsuitable
- Insufficient knowledge of English to complete the daily bowel diary and food diary.
- Hypersensitivity to any component of the supplement
- Hypersensitivity or known allergy to lactulose or mannitol.
- Consumption of oral antibiotics in the last 2 weeks.
- 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).
- Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
- Diabetes mellitus (type 1).
- Participants with known hepatic disease.
- Inflammatory bowel disease (Crohn's/Colitis) or coeliac disease.
- Gastrointestinal infection in the past 4 weeks.
- Any other condition, deemed by the investigator, that may be causing their symptoms.
- Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06543498
Start Date
August 1 2024
End Date
January 13 2025
Last Update
June 24 2025
Active Locations (2)
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1
The Functional Gut Clinic
London, United Kingdom, NW1 6PU
2
The Functional Gut Clinic
Manchester, United Kingdom, M3 4BG