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| ID | Type | Description | Link |
|---|---|---|---|
| 14GA006 | Other Identifier | Nottingham University Hospitals NHS Trust |
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| Name | Class |
|---|---|
| Ironwood Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.
The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | 7 days without use of laxatives other than standardised rescue therapy 7 grams maltodextrin taken 3 times daily, at least 4 hours apart, for up to 7 days |
|
| Ispaghula | Active Comparator | 7 days without use of laxatives other than standardised rescue therapy 7 grams ispaghula/ psyllium taken 3 times daily, at least 4 hours apart, for up to 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ispaghula | Dietary Supplement |
|
| |
| Maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average Position Score of transit marker capsules as determined by MRI | After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position | 24 hours after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average Position Score of 5 transit marker capsules, as determined by MRI | After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position | 48 hours after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Colonic volume | Area under the curve (mL.min) will be measured from hourly MRI scans by segmentation into ascending colon (AC), transverse colon (TC) and descending colon (DC) | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Colonic gas volume |
Inclusion Criteria:
Exclusion Criteria:
During the screening 2 weeks off laxatives
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| Name | Affiliation | Role |
|---|---|---|
| Robin Spiller, MSc MD FRCP | University of Nottingham | Study Chair |
| Giles Major, BM BCh MRCP | University of Nottingham | Principal Investigator |
| Luca Marciani, MSc PhD | University of Nottingham | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom | |||
| University of Nottingham |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Dietary Supplement |
|
| Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI | Area under the curve (mL.min) will be calculated from hourly MRI scans | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Small Bowel Water Content (SBWC) in millilitres measured by MRI | After 5 days of taking the study product participants will undergo an MRI scan while fasted. | Baseline, 60 minutes before test meal |
| Ascending Colon Water Content in millilitres measured by MRI | After 5 days taking study product participants will undergo an MRI scan while fasted | Baseline, 60 minutes before test meal |
| Ascending Colon Water Content in millilitres measured by MRI | Area under the curve (mL.min) will be calculated from hourly MRI scans | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Change from baseline in Ascending Colon Water Content in millilitre measured by MRI | Difference between measurement Meal -60 (fasting) and Meal +60 | test meal -60, test meal +60 |
| Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI | Difference between time points Meal2 -20 and Meal 2 +40 | test meal +360 minutes, test meal + 420 minutes |
| Ascending Colon T1 | Area under the curve of MRI parameter measured at hourly time points | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Descending Colon T1 | Area under the curve of MRI parameter measured at hourly time points | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Ascending colon T2 | Area under the curve of MRI parameter measured at hourly time points | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Descending Colon T2 | Area under the curve of MRI parameter measured at hourly time points | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
Area under the curve (mL.min), measured on hourly MRI scans by segmentation into AC, TC and DC |
| -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Gastric volume | Area under the curve (mL.min) measured on hourly MRI scans | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Abdominal circumference | Measured at the umbilicus in cm, determined by MRI | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Change from baseline of stool water content percentage by mass | Stool will be sampled during the baseline week and between days 3-7 of the intervention week during each treatment period | after an average 5 days of intervention |
| Change from baseline in stool frequency | Each treatment period includes 1 day washout, 7 days baseline, up to 7 (minimum 6) days intervention. Total = 15 days. Stool frequency will be sampled on days 2-8 and 9-14, since participants may stop taking intervention before day 15. | during days 9-14 of treatment period |
| Change from baseline in stool consistency | Each treatment period includes 1 day washout, 7 days baseline, up to 7 (minimum 6) days intervention. Total = 15 days. Stool consistency will be sampled on days 2-8 and 9-14, since participants may stop taking intervention before day 15. | During days 9-14 of treatment period |
| Change from baseline in faecal microbiota | Will be assessed for relative abundance, richness and diversity | Change from baseline after an average 5 days of intervention |
| Change from baseline in faecal short-chain fatty acids | Stool samples collected during baseline week and after 3 or more days of intervention in each treatment period. | Change from baseline after an average 5 days of intervention |
| Symptoms during study day | 4 symptoms will be measured on 2 scales: a previously validated questionnaire on an ordinal scale (OS) of 0 (none), 1 (mild/ distinct but negligible), 2 (moderate/ annoying), 3 (severe/ disabling); and a Visual Analogue Scale (VAS) (0-100) Symptoms include abdominal pain, bloating, gas/flatulence, and diarrhoea. Clinically important symptoms will be defined as additive total score of 3 or greater on OS. VAS scores will be analysed alongside MRI data | -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal |
| Nottingham |
| NG7 2UH |
| United Kingdom |