MRI and Microbiota Analysis in Constipation

NCT02144376 | Completed

• 2 other identifiers: UON1401114GA006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Constipation

Keywords

Constipation; psyllium; ispaghula; Magnetic Resonance Imaging; MRI; microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Weighted Average Position Score of 5 transit marker capsules, as determined by MRI

  48 hours after ingestion

• Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI

  -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

• Small Bowel Water Content (SBWC) in millilitres measured by MRI

  Baseline, 60 minutes before test meal

• Ascending Colon Water Content in millilitres measured by MRI

  Baseline, 60 minutes before test meal

• Ascending Colon Water Content in millilitres measured by MRI

  -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

Other Outcomes (10)

• Colonic volume

  -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

• Colonic gas volume

  -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

• Gastric volume

  -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

Study Arms (2)

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

Dietary Supplement: Maltodextrin

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

Dietary Supplement: Ispaghula

Interventions

Ispaghula DIETARY_SUPPLEMENT

Also known as: psyllium

Ispaghula

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Ironwood Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Interventions

Psyllium; maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: May 22, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)