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Trial record 52 of 562 for:    maltodextrin

MRI and Microbiota Analysis in Constipation (MIMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02144376
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : January 5, 2017
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Ispaghula Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Maltodextrin
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
Dietary Supplement: Maltodextrin
Active Comparator: Ispaghula
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
Dietary Supplement: Ispaghula
Other Name: psyllium




Primary Outcome Measures :
  1. Weighted Average Position Score of transit marker capsules as determined by MRI [ Time Frame: 24 hours after ingestion ]
    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


Secondary Outcome Measures :
  1. Weighted Average Position Score of 5 transit marker capsules, as determined by MRI [ Time Frame: 48 hours after ingestion ]
    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

  2. Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve (mL.min) will be calculated from hourly MRI scans

  3. Small Bowel Water Content (SBWC) in millilitres measured by MRI [ Time Frame: Baseline, 60 minutes before test meal ]
    After 5 days of taking the study product participants will undergo an MRI scan while fasted.

  4. Ascending Colon Water Content in millilitres measured by MRI [ Time Frame: Baseline, 60 minutes before test meal ]
    After 5 days taking study product participants will undergo an MRI scan while fasted

  5. Ascending Colon Water Content in millilitres measured by MRI [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve (mL.min) will be calculated from hourly MRI scans

  6. Change from baseline in Ascending Colon Water Content in millilitre measured by MRI [ Time Frame: test meal -60, test meal +60 ]
    Difference between measurement Meal -60 (fasting) and Meal +60

  7. Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI [ Time Frame: test meal +360 minutes, test meal + 420 minutes ]
    Difference between time points Meal2 -20 and Meal 2 +40

  8. Ascending Colon T1 [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve of MRI parameter measured at hourly time points

  9. Descending Colon T1 [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve of MRI parameter measured at hourly time points

  10. Ascending colon T2 [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve of MRI parameter measured at hourly time points

  11. Descending Colon T2 [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve of MRI parameter measured at hourly time points


Other Outcome Measures:
  1. Colonic volume [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    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)

  2. Colonic gas volume [ Time Frame: -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

  3. Gastric volume [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Area under the curve (mL.min) measured on hourly MRI scans

  4. Abdominal circumference [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]
    Measured at the umbilicus in cm, determined by MRI

  5. Change from baseline of stool water content percentage by mass [ Time Frame: after an average 5 days of intervention ]
    Stool will be sampled during the baseline week and between days 3-7 of the intervention week during each treatment period

  6. Change from baseline in stool frequency [ Time Frame: during days 9-14 of treatment period ]

    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.


  7. Change from baseline in stool consistency [ Time Frame: During days 9-14 of treatment period ]

    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.


  8. Change from baseline in faecal microbiota [ Time Frame: Change from baseline after an average 5 days of intervention ]
    Will be assessed for relative abundance, richness and diversity

  9. Change from baseline in faecal short-chain fatty acids [ Time Frame: Change from baseline after an average 5 days of intervention ]
    Stool samples collected during baseline week and after 3 or more days of intervention in each treatment period.

  10. Symptoms during study day [ Time Frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible)
  • At least one bowel motion per week while taking usual laxatives
  • Able to give informed consent
  • Aged 18 or older

Exclusion Criteria:

  • History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to:
  • Inflammatory Bowel Disease
  • Coeliac Disease diagnosed in the last year
  • Pancreatitis
  • Cancer of the gastrointestinal tract
  • Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
  • Presence of an intestinal stoma
  • Pregnancy declared by candidate (no formal testing)
  • Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
  • Reported alcohol intake of >28 units/ week with daily drinking
  • Any use of a product containing ispaghula or psyllium in the 4 weeks prior to consent
  • Unable to avoid use of dihydrocodeine or morphine during the study
  • If taking other regular opiates such as codeine, fentanyl or Oxycodone, participants should be able to maintain a stable dose throughout the study
  • Any reported history of hypersensitivity or significant adverse reaction to ispaghula, maltodextrin or bisacodyl
  • Unable to stop drugs and other agents used primarily for their laxative effect, during periods of screening, washout, baseline and treatment (maximum 15 days - rescue medication will be provided).
  • Antibiotic or prescribed probiotic treatment in the past 4 weeks
  • Inability to lie flat or exceed scanner limits of weight <120kg
  • Poor understanding of English language
  • Participation in any medical trials for the past 3 months
  • Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
  • Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD

During the screening 2 weeks off laxatives

  • No bowel motions recorded during screening period
  • ≥3 complete spontaneous bowel motions (CSBMs - bowel motion with the feeling of complete evacuation, without the use of rescue therapy in the preceding 24 hours) per week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144376


Locations
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United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Ironwood Pharmaceuticals, Inc.
Investigators
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Study Chair: Robin Spiller, MSc MD FRCP University of Nottingham
Principal Investigator: Giles Major, BM BCh MRCP University of Nottingham
Study Director: Luca Marciani, MSc PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02144376     History of Changes
Other Study ID Numbers: UON14011
14GA006 ( Other Identifier: Nottingham University Hospitals NHS Trust )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Nottingham:
Constipation
psyllium
ispaghula
Magnetic Resonance Imaging
MRI
microbiota
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals