Status:
COMPLETED
Low Residue Diet Study in Mitochondrial Disease
Lead Sponsor:
Newcastle University
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
Conditions:
Mitochondrial Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Slow movement of patients guts is referred to as intestinal dysmotility, and is increasingly recognised as a debilitating manifestation of mitochondrial disease both in adults and children. To date, ...
Detailed Description
Intestinal dysmotility is increasingly recognised as a debilitating manifestation of mitochondrial disease both in adults and children (1). It is a frequent symptom of other neurological conditions in...
Eligibility Criteria
Inclusion
- Male or female, aged 18 and over.
- Genetic or biochemical confirmation of mitochondrial disease.
- ROME III criteria of constipation (Appendix 2).
- Stable gastrointestinal drug regimen prior to commencement of study, at least 3 months prior study inclusion.
- No known hypersensitivities to any of the ingredients in the preparations.
- Not already implementing a low residue diet.
- Competent to make such decisions in the opinion of the investigator.
- Females of child bearing age require a negative pregnancy test.
Exclusion
- Patients with known allergies to any adjuncts in the dietary preparation
- Patients with bowel obstruction
- Females who are pregnant, lactating or planning a pregnancy.
- Planned surgery during the course of the trial.
- Participation in another drug trial concurrently or in the preceding 12 weeks.
- Any condition which would put the participant at risk if they were to take part in the trial.
Key Trial Info
Start Date :
September 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03388528
Start Date
September 8 2017
End Date
February 7 2019
Last Update
October 11 2019
Active Locations (1)
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1
Grainne Gorman
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE2 4HH