Clinical trial NCT06543498: The Effect of Dietary Supplementation on Intestinal Barrier Function in IBS-D
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome with Diarrhea
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in intestinal permeability
timeFrame: Day 0 vs Day 21
Secondary outcomes:
measure: Serum LPS
timeFrame: Day 0 vs Day 21
measure: Serum LPB
timeFrame: Day 0 vs Day 21
measure: Serum sCD14
timeFrame: Day 0 vs Day 21
measure: Serum Zonulin
timeFrame: Day 0 vs Day 21
measure: Serum Occludin
timeFrame: Day 0 vs Day 21
measure: Serum LCN12
timeFrame: Day 0 vs Day 21
measure: Rescue medication
timeFrame: Mean Day 0-6 vs Mean Day 15-21
measure: Loperamide utilisation
timeFrame: Mean Day 0-6 vs Mean Day 15-21
measure: Irritable bowel severity scoring system
timeFrame: Day 0 vs Day 21
measure: Stool consistency
timeFrame: Day -14 to -1 vs Day 0 to 21
measure: Stool consistency
timeFrame: Mean Day 0-6 vs Mean Day 15-21
measure: Stool frequency
timeFrame: Day -14 to -1 vs Day 0 to 21
measure: Stool frequency
timeFrame: Mean Day 0-6 vs Mean Day 15-21
measure: Bloating
timeFrame: Day -14 to -1 vs Day 0 to 21
measure: Bloating
timeFrame: Mean Day 0-6 vs Mean Day 15-21
measure: Abdominal pain
timeFrame: Day -14 to -1 vs Day 0 to 21
measure: Abdominal pain
timeFrame: Mean Day 0-6 vs Mean Day 15-21
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Functional Gut Clinic
city: Manchester
country: United Kingdom
facility: The Functional Gut Clinic
Study officials:
References: