Low Residue Diet Study in Mitochondrial Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03388528
• Date of registration: 27/10/2017
• Prospective Registration: No
• Primary sponsor: Newcastle University
• Public title: Low Residue Diet Study in Mitochondrial Disease LRD
• Scientific title: Phase II Feasibility Study of the Efficacy and Acceptability of a Low Residue Diet in Adult Patients With Mitochondrial Disease
• Date of first enrolment: September 8, 2017
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03388528
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Grainne S Gorman, MD
• Affiliation: Newcastle University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mitochondrial Diseases

Intervention(s)

Dietary Supplement: Low Residue Diet Intervention

Primary Outcome(s)

Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients [Time Frame: Change from baseline to 12 weeks]

Stool Frequency and consistency [Time Frame: Change from baseline to 12 weeks]

Secondary Outcome(s)

Biochemistry [Time Frame: Change from baseline to 12 weeks]

Gastrointestinal Dysmotility [Time Frame: Change from baseline to 12 weeks]

Food Intake [Time Frame: Change from baseline to 12 weeks]

Anthropometrics [Time Frame: Change from baseline to 12 weeks]

Colonic Transit Time [Time Frame: Change from baseline to 12 weeks]

Disease Burden [Time Frame: Change from baseline to 12 weeks]

Gut Microbiome Comparison [Time Frame: Baseline only (prior to any intervention)]

Physical Activity [Time Frame: Change from baseline to 12 weeks]

Gastrointestinal Health [Time Frame: Change from baseline to 12 weeks]

Physical Dimensions [Time Frame: Change from baseline to 12 weeks]

Gut Microbiome changes [Time Frame: Change from baseline to 12 weeks]

Haematology [Time Frame: Change from baseline to 12 weeks]

Physical Measurements [Time Frame: Change from baseline to 12 weeks]

Secondary ID(s)

17/NE/0193

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Newcastle-upon-Tyne Hospitals NHS Trust