Low Residue Diet Study in Mitochondrial Disease

NCT03388528 | Completed DMC

• 1 other identifier: 17/NE/0193
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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, symptoms of slow gut movements have been managed with laxatives and drugs that increase movement of the guts with variable results. A low residue diet is a form of low fibre diet (\<10g fibre per day) that is used to minimise symptoms of poor movement of the guts. This reduces fecal volume and bulk, and hence gut workload, ensuring limited bowel activity and colonic rest. It has been shown to be well accepted in other conditions associated with slow gut movements. However, its role in patients with mitochondrial disease is unknown. The investigators are particularly interested in:

• Does a low residue diet (low fibre) cause a change in the number of stools per week and stool consistency?
• Is a low residue diet tolerated well and easy to comply with?
• Does a low residue diet reduce gut symptoms of abdominal pain, bloating, and constipation?
• Does a low residue diet improve quality of life and disease burden?
• Does a low residue diet affect the bacteria in the gut?
• Can we prove by X-ray that movement of food through the gut is slowed in patients with mitochondrial disease, and whether a low residue diet alters the speed of movement of food through the gut?
• Can a low residue diet change patients physical activity levels?
• Does a low reside diet change dietary patterns and food intake?
• Does a low residue diet alter anthropometrics, such as weight, body mass index and waist to hit ratio?
• Can a low residue diet improve kidney and liver function and lipid profile in blood samples? The investigators hope that by looking at these areas that a low residue diet may be able to improve patients slow gut movements, health, quality of life and disease burden.

Conditions

Mitochondrial Diseases

Keywords

Dysmotility; Microbiome; Transit Time; Gastrointestinal

Outcome Measures

Primary Outcomes (2)

• Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients

  Tolerability of the LRD will be assessed using food diaries

  Change from baseline to 12 weeks

• Stool Frequency and consistency

  Assess stool consistency according to the Bristol Stool Form scale. Patients will select from the following to describe their stool consistency: Type 1: Separate hard lumps, like nuts Type 2: Sausage-like but lumpy Type 3: Like a sausage but with cracks in the surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear-cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces

  Change from baseline to 12 weeks

Secondary Outcomes (13)

• Gastrointestinal Dysmotility

  Change from baseline to 12 weeks

• Disease Burden

  Change from baseline to 12 weeks

• Gut Microbiome changes

  Change from baseline to 12 weeks

• Gut Microbiome Comparison

  Baseline only (prior to any intervention)

• Food Intake

  Change from baseline to 12 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

This is a single arm study where forty patients with a genetically or biochemically proven diagnosis of mitochondrial disease will be recruited from the mitochondrial CRESTA clinic and / or Medical Research Council Mitochondrial Disease Patient Cohort Study in Newcastle. All forty patients will be assessed prior to and following a 12 week low residue diet study intervention.

Dietary Supplement: Low Residue Diet Intervention

Interventions

Low Residue Diet Intervention DIETARY_SUPPLEMENT

All patients will be provided with a LRD plan (\< 10g fibre per day) for 12 weeks between visits 2 and 3. They will also be supplemented with multivitamin and mineral tablet or liquid (Forceval) to meet nutrient requirements (prescribed as standard care). The dietitian will provide written and oral information about the LRD and weekly telephone calls to assess patient's progress on the diet.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 and over.
• Genetic or biochemical confirmation of mitochondrial disease.
• ROME III criteria of constipation (Appendix 2).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Grainne Gorman

Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom

Location

Related Publications (1)

• Houghton D, Ng YS, Jackson MA, Stefanetti R, Hynd P, Mac Aogain M, Stewart CJ, Lamb CA, Bright A, Feeney C, Newman J, Turnbull DM, McFarland R, Blain AP, Gorman GS. Phase II Feasibility Study of the Efficacy, Tolerability, and Impact on the Gut Microbiome of a Low-Residue (Fiber) Diet in Adult Patients With Mitochondrial Disease. Gastro Hep Adv. 2022 Jul 1;1(4):666-677. doi: 10.1016/j.gastha.2022.03.007. eCollection 2022.

  PMID: 39132075 DERIVED

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Grainne S Gorman, MD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Forty patients with a genetically or biochemically proven diagnosis of mitochondrial disease will be recruited from the mitochondrial Clinics for Research and Service in Themed Assessments (CRESTA) clinic and / or Medical Research Council Mitochondrial Disease Patient Cohort Study in Newcastle

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: January 3, 2018
• Study Start: September 8, 2017
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)