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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCT and NFT | Active Comparator | 21 days of 1x capsule per day. Dosage 120mg. |
|
| Placebo | Placebo Comparator | 21 days of 1x placebo capsule per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose/Mannitol Ratio Test | Diagnostic Test | To test for gut permeability, Urine collected over 8hrs after ingestion of lactulose/mannitol drink. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in intestinal permeability | Lactulose mannitol ratio change in urine from baseline to end of treatment | Day 0 vs Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum LPS | Comparison of start to end of study between active and placebo groups | Day 0 vs Day 21 |
| Serum LPB | Comparison of start to end of study between active and placebo groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Functional Gut Clinic | London | NW1 6PU | United Kingdom | |||
| The Functional Gut Clinic |
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| Serum biomarkers of intestinal permeability | Diagnostic Test | Phlebotomy and subsequent lab tests to analyse concentration of LPS, LPB, sCD14, Zonulin and Occludin. |
|
| Rome IV questionnaire | Other | Diagnositic questionnaire for IBS-D |
|
| Irritable bowel severity scoring system | Other | Questionnaire to determine severity of abdominal and bowel symptoms |
|
| Bowel Habit diary | Other | Assess bowel habit at baseline and changes in bowel habit over the study |
|
| 3 day dietary record | Other | Used to verify compliance to exclusion criteria #5. |
|
| NCT and NFT | Dietary Supplement | N-transcaffeoyltyramine and N-transferuloyltyramine supplement taken once per day. |
|
| Placebo | Other | Placebo supplement taken once per day. |
|
| Day 0 vs Day 21 |
| Serum sCD14 | Comparison of start to end of study between active and placebo groups | Day 0 vs Day 21 |
| Serum Zonulin | Comparison of start to end of study between active and placebo groups | Day 0 vs Day 21 |
| Serum Occludin | Comparison of start to end of study between active and placebo groups | Day 0 vs Day 21 |
| Serum LCN12 | Comparison of start to end of study between active and placebo groups | Day 0 vs Day 21 |
| Rescue medication | Use of rescue medication - number of days required during treatment period first week vs last week. | Mean Day 0-6 vs Mean Day 15-21 |
| Loperamide utilisation | Difference between active and placebo groups | 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. | Day 0 vs Day 21 |
| Stool consistency | Average number of days of Bristol stool scale 6-7 stools during screening vs treatment period | 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 | Mean Day 0-6 vs Mean Day 15-21 |
| Stool frequency | Comparison of mean number of bowel movements per day screening vs treatment period. | 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. | 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. | 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. | 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. | 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. | Mean Day 0-6 vs Mean Day 15-21 |
| Manchester |
| M3 4BG |
| United Kingdom |
| ID | Term |
|---|---|
| D015930 | Diet Records |
| ID | Term |
|---|---|
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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