Colonic Motility in Constipation and Ageing

NCT02575742 | Completed

• 1 other identifier: ReDA-010366 QM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Ageing; Constipation

Outcome Measures

Primary Outcomes (1)

• Total colonic transit time

  Colonic transit time as measured by 3D transit system

  2 to 5 days

Study Arms (4)

Young women without chronic constipation

Healthy women without chronic constipation who are aged between 18-40 years

Device: 3D-Transit system

Older women without chronic constipation

Healthy women without chronic constipation who are aged between 70-90 years

Device: 3D-Transit system

Young women with chronic constipation

Women with symptoms of chronic constipation who are aged between 18-40 years

Device: 3D-Transit system

Older women with chronic constipation

Women with symptoms of chronic constipation who are aged between 70-90 years

Device: 3D-Transit system

Interventions

3D-Transit system DEVICE

Older women with chronic constipation; Older women without chronic constipation; Young women with chronic constipation; Young women without chronic constipation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 women aged 18-40 years (15 non-constipated women, 15 with chronic constipation) and 30 women aged between 70-90 years (15 non-constipated women, 15 with chronic constipation) will be recruited, via advertisement in the community.

You may qualify if:

• Aged 18-40 or 70-90 years of age
• Barthel index ≥11 \[for elderly women only\]
• No co-existing acute or chronic diseases at the time of recruitment (except hypertension and hypercholesterolemia for elderly women)
• Patients with self-reported problematic constipation
• Cleveland Clinic Constipation Score ≥8
• Bowel movement frequency \<3 per week
• Stool consistency of 1-3 on the Bristol Stool Chart
• No evidence of organic causes of constipation
• Symptoms of constipation (unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least the previous 3 months)
• Healthy women aged 18-40 or 70-90 years of age
• No co-existing acute or chronic diseases at the time of recruitment (except hypertension and hypercholesterolemia for elderly women)
• Barthel index ≥11 \[for elderly women only\]
• Cleveland Clinic Constipation Score \<8

You may not qualify if:

• Inability to understand written and spoken English
• Lacking capacity to understand subject information sheet and give informed consent
• Vulnerable subject groups (e.g. elderly with dementia)
• Pregnancy, intention to become pregnant, or breastfeeding during study period
• Recent childbirth in the last 6 months
• Other causes of reduced / dysregulated GI motility and secondary constipation
• Conditions which make it unsafe to use the capsules

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E1 2AJ, United Kingdom

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Scott, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: October 15, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: January 13, 2023

Record last verified: 2015-10

Locations

GB (1)