The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea

• Registration Number: NCT06543498
• Lead Sponsor: Dr Anthony Hobson

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 mixed IBS (IBS-M). Around 24% of those suffering with IBS have the diarrhoea variant.

IBS-D has been shown to greatly impact sufferers' quality of life and there is currently a lack of well tolerated therapies to treat this condition. Therefore, it is of upmost important to find safe and effective non-pharmacological treatments for this condition.

Two natural compounds which may interact with the body NCT and NFT have been identified in a range of edible sources and can be involved in processes that help maintain an effective gut barrier and therefore potentially help treat a leaky gut.

This research study aims to examine the effectiveness of these compounds, NCT and NFT in combination compared to a placebo (capsule that looks the same as the study product but contains no active study ingredient) capsule on gut barrier function in individuals suffering from IBS-D.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-23
• Study Start: 2024-08-01
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Primary Completion: 2025-01-13
• Study Completion: 2025-01-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in intestinal permeability	Day 0 vs Day 21	Lactulose mannitol ratio change in urine from baseline to end of treatment

Secondary Outcome Measures

Name	Time	Method
Serum sCD14	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups
Serum Zonulin	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups
Irritable bowel severity scoring system	Day 0 vs Day 21	Change in mean score at end of treatment vs start. Minimum score 0, maximum 500. Higher score indicates worse symptoms.
Serum LPS	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups
Serum Occludin	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups
Rescue medication	Mean Day 0-6 vs Mean Day 15-21	Use of rescue medication - number of days required during treatment period first week vs last week.
Abdominal pain	Mean Day 0-6 vs Mean Day 15-21	Comparison of mean daily abdominal pain score first vs last week of treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Loperamide utilisation	Mean Day 0-6 vs Mean Day 15-21	Difference between active and placebo groups
Stool consistency	Mean Day 0-6 vs Mean Day 15-21	Average number of days of Bristol stool scale 6-7 stools comparison of first vs last week of treatment period
Bloating	Mean Day 0-6 vs Mean Day 15-21	Comparison of mean daily bloating score first vs last week of treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Serum LCN12	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups
Stool frequency	Mean Day 0-6 vs Mean Day 15-21	Comparison of mean number of bowel movements per day first vs last week of treatment period.
Serum LPB	Day 0 vs Day 21	Comparison of start to end of study between active and placebo groups

Trial Locations

Locations (1)

The Functional Gut Clinic; 🇬🇧 Manchester, United Kingdom