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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink.
Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin.
Diagnositic questionnaire for IBS-D
Questionnaire to determine severity of abdominal and bowel symptoms
Assess bowel habit at baseline and changes in bowel habit over the study
Used to verify compliance to exclusion criteria #5.
N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day.
Placebo supplement taken once per day.
The Functional Gut Clinic
London, United Kingdom
The Functional Gut Clinic
Manchester, United Kingdom
Change in intestinal permeability
Lactulose mannitol ratio change in urine from baseline to end of treatment
Time frame: Day 0 vs Day 21
Serum LPS
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Serum LPB
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Serum sCD14
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Serum Zonulin
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Serum Occludin
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Serum LCN12
Comparison of start to end of study between active and placebo groups
Time frame: Day 0 vs Day 21
Rescue medication
Use of rescue medication - number of days required during treatment period first week vs last week.
Time frame: Mean Day 0-6 vs Mean Day 15-21
Loperamide utilisation
Difference between active and placebo groups
Time frame: Mean Day 0-6 vs Mean Day 15-21
Irritable bowel severity scoring system
Change in mean score at end of treatment vs start. Minimum score 0, maximum 500. Higher score indicates worse symptoms.
Time frame: Day 0 vs Day 21
Stool consistency
Average number of days of Bristol stool scale 6-7 stools during screening vs treatment period
Time frame: Day -14 to -1 vs Day 0 to 21
Stool consistency
Average number of days of Bristol stool scale 6-7 stools comparison of first vs last week of treatment period
Time frame: Mean Day 0-6 vs Mean Day 15-21
Stool frequency
Comparison of mean number of bowel movements per day screening vs treatment period.
Time frame: Day -14 to -1 vs Day 0 to 21
Stool frequency
Comparison of mean number of bowel movements per day first vs last week of treatment period.
Time frame: Mean Day 0-6 vs Mean Day 15-21
Bloating
Comparison of mean daily bloating score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Time frame: Day -14 to -1 vs Day 0 to 21
Bloating
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.
Time frame: Mean Day 0-6 vs Mean Day 15-21
Abdominal pain
Comparison of mean daily abdominal pain score screening vs treatment period. Minimum score is 0, Maximum score is 3. Higher score indicates more symptoms.
Time frame: Day -14 to -1 vs Day 0 to 21
Abdominal pain
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.
Time frame: Mean Day 0-6 vs Mean Day 15-21
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