NCT & NFT Leaky Gut
Research type
Research Study
Full title
The effect of Bioactive compounds NCT and NFT on intestinal barrier function in participants with Irritable Bowel Syndrome with Diarrhoea
IRAS ID
344580
Contact name
Anthony Hobson
Contact email
Sponsor organisation
The Functional Gut Clinic
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Summary of Research
Irritable bowel syndrome is a debilitating condition that affects around 10% of the UK population. Of those suffering, around 25% have the diarrhoea (IBS-D) variant of the condition. Several potential mechanisms have been potentially identified as a contributing factor or associated with IBS-D, one of those being increased intestinal permeability, sometimes referred to as a 'leaky gut'.There is currently a lack of treatment options for IBS-D and the satisfaction of sufferers if generally relatively poor. Targeting potential underlying mechanisms may help subsets of those suffering with IBS-D.
NFT and NCT are two bioactive compounds considered a dietary/nutritional supplement, found in a range of edible sources (such as black pepper) that have been shown to elicit an effect on cell signalling pathways and reduction of intestinal permeability.
This pilot study, aims to test whether NFT+NCT can reduce intestinal permeability and improve symptoms in patients with IBS-D compared to a placebo capsule. The study will utilise a single blind, randomised design, with a ~3 week screening period and 3 week treatment period.
The study is first and foremost a pilot study to assess initial effect of the product on gut barrier function that could help to power a large study.
Summary of Results
32 participants with moderate to severe Irritable bowel syndrome with diarrhoea were enrolled into the study. Complete data from 29 individuals (18 female) were analysed. 3 participants withdrew from the study and had no data from the treatment available for analysis.At baseline participants underwent lactulose mannitol intestinal permeability testing at baseline and end of study as the primary assessment of gut barrier function. They also had blood taken for several blood based biomarkers linked to gut barrier function and completed questionnaires on their symptoms. They were randomised 1:1 to NCTNFT or placebo. Treatment period was three weeks, for which period they completed a daily diary about their symptoms and bowel habit. Participants returned after 3 weeks for repeat assessments.
Within the NCTNFT group their was a significant improvement in gut barrier function measured by lactulose mannitol intestinal permeability testing. When compared to placebo, NCTNFT showed greater improvement than placebo in gut barrier function but this did not reach statistical significance. Blood based biomarker LBP showed a significant decrease compared to placebo, for all other blood based biomarkers there was no significant difference. Total IBS symptom severity score decreased in both groups, however a larger decrease was seen in the NCTNFT group, this did not reach statistical significance, however when symptoms were looked at individually, bloating was significantly improved in the NCTNFT group compared to the placebo group.
There were no adverse events (side effects) attributed to use of the study product or placebo in the study.
To conclude, NCT & NFT may reduce intestinal permeability and bloating in patients with IBS-D. Further research of these bioactive compounds should be carried out in a larger sample size to further elucidate these findings.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0442
Date of REC Opinion
17 Jul 2024
REC opinion
Further Information Favourable Opinion