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Colonic Motility in Constipation and Ageing

NCT02575742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-01-13

No results posted yet for this study

Summary

The reason chronic constipation (CC) becomes commoner with age is not fully understood. New studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are important and may differ in older people. Since CC reduces quality of life and is a major reason why elderly are admitted to hospitals and residential care, there is a need to understand how these factors change with age.

Currently, placing a pressure sensing catheter inside the large intestine (pancolonic manometry) is the gold standard way to measure how well it contracts. However this involves a camera test (colonoscopy) which is invasive with risks of bowel perforations (\~80/100,000). The risk is higher with age (64-80yr: \~90/100,000; 80+yrs: \~120/100,000), making it unethical for elderly.

A technique called the 3D-Transit System has been developed, involving a small ingestible capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule swallowed by participants, it provides precise detailed information on the capsule progression inside the whole gut and large bowel's contractile activity in real-time. It is minimally-invasive and radiation-free, making it possible to assess elderly for the first time.

This study aims to assess how bowel contraction patterns, dietary fibre intake and gut bacteria differ between young and older adults (with and without CC), to better understand why CC is more common in elderly.

It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3 weeks, containing 2 weeks of run-in period and 1 week of study period.

The four groups participants will be asked to: swallow 2 capsules to assess their large bowel's contractile function using the 3D-transit system; provide stool samples to analyses their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.

Conditions

Interventions

DEVICE

3D-Transit system

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Mark Scott, PhD · Queen Mary University of London

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575742 on ClinicalTrials.gov