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Completed

NCT Number: NCT02144376

MRI and Microbiota Analysis in Constipation

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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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ispaghula

Dietary Supplement

Other names: psyllium

Maltodextrin

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Ironwood Pharmaceuticals, Inc.

Registry information

Official study title

Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation

Acronym: MIMIC

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 22, 2014
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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