Ispaghula and Colonic Water Content

NCT01805999 | Completed

• 1 other identifier: H13122012SCS
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide. Bulking agents such as ispaghula are used as treatments, but only half of the patients are satisfied with the treatment. This highlights a need for better treatment options, which requires a deeper understanding of the gastrointestinal fate of the products. The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with Ironwood Pharmaceuticals, the investigators now want to understand the gastrointestinal fate of an ispaghula treatment, and also to improve the understanding of MRI parameters when they are applied to the colon.

Conditions

Healthy

Keywords

Ispaghula; Gastrointestinal physiology; Gastrointestinal response to sugars; MRI; gastrointestinal; stomach; small bowel; colon

Outcome Measures

Primary Outcomes (1)

• ascending colon free water content (ACWC)

  An assessment of the volume of water in the ascending colon, as obtained from MR images

  0 - 360 minutes

Secondary Outcomes (4)

• Ascending, transverse and descending colon volumes

  0 - 360 minutes

• Geometric centres (GC) 24 and 48 hours

  t = 24 hours and t = 48 hours

• Small bowel water content

  0 - 360 minutes

• Gastric emptying

  0 - 360 minutes

Study Arms (3)

7 g Ispaghula

EXPERIMENTAL

Volunteer will take 7 g of ispaghula 3 times daily for one week

Dietary Supplement: 7 g Ispaghula

7 g placebo

PLACEBO COMPARATOR

Volunteer will take 7 g of a placebo 3 times a day for one week

Dietary Supplement: 7 g placebo

3.5g ispaghula + 3.5 g placebo

ACTIVE COMPARATOR

Volunteers will take 3.5 g of ispaghula with 3.5 g placebo 3 times daily for one week

Dietary Supplement: 3.5g Ispaghula + 3.5 g placebo

Interventions

7 g Ispaghula DIETARY_SUPPLEMENT

Also known as: Metamucil

7 g Ispaghula

7 g placebo DIETARY_SUPPLEMENT

7 g placebo

3.5g Ispaghula + 3.5 g placebo DIETARY_SUPPLEMENT

3.5g ispaghula + 3.5 g placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy; free from GI disorders, aged 18 and 65 years of age
• Male or female
• Body mass index (BMI) between 18.0 and 30.0 kg m-2
• Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire
• No known gastrointestinal disease
• Not currently smoking
• No strenuous exercise greater than 10 hours per week
• No consumption of more than 21 units of alcohol in a typical week
• No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.

You may not qualify if:

• Inability to discontinue medication likely to alter GI transit
• Antibiotics in the 3 weeks before the pre-study examination
• Pre-existing condition making the need for antibiotics likely during the study
• Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
• Known inflammatory bowel disease; coeliac disease
• Subjects considered by the investigator unlikely to comply with study protocol
• Regular (\>3 times/week) use of Probiotics in the 3 weeks prior to, or during the study

Sponsors & Collaborators

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

Study Sites (1)

NDD BRU and Sir Peter Mansfield Magnetic Resonance Centre

Nottingham, Nottinghamshire, NG7 2RD, United Kingdom

Location

MeSH Terms

Interventions

Psyllium

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Robin Spiller, MD, FRCP

  University of Nottingham

  STUDY CHAIR

• Jeffrey Johnston, MD, FACP

  Ironwood Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Luca Marciani, Laurea, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Kathryn Murray, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Giles Major, MB BChir

  University of Nottiingham

  PRINCIPAL INVESTIGATOR

• Ching Lam, MB BCh

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Caroline Hoad, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Penny Gowland, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 6, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

GB (1)