Role of low residue diet in managing symptoms of mitochondrial disease
Research type
Research Study
Full title
Phase II feasibility study of the efficacy and acceptability of a low residue diet in adult patients with mitochondrial disease.
IRAS ID
221511
Contact name
Grainne Gorman
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Mitochondria are tiny structures within cells that contain their own genetic material (DNA) and play a critical role in cellular energy (ATP) production. When these 'powerhouses' malfunction, it may result in chronic illnesses known as mitochondrial diseases.
Mitochondrial diseases are a complex group of inherited conditions in which children and adults are more susceptible to developmental, physical and cognitive disabilities. Gut symptoms (that involve the gullet, stomach and bowels) are frequently reported and often debilitating. Symptoms include abdominal pain, bloating, severe constipation and occasionally may mimic an obstruction in the bowel, requiring admission to hospital. These symptoms, ultimately result from the slow movement of food and stool through the gut, due to malfunctioning mitochondria. It has been estimated that mitochondrial diseases affect up to 15,000 children and a similar numbers of adults, in the UK. Hence whilst, to date, there are no licensed treatments nor curative therapies, there is an urgent need to find effective symptomatic treatments.
We plan to test a ‘low residue’ diet that has been originally used in people who need to avoid foods that may irritate an inflamed bowel or may obstruct narrowed parts of the bowel. ‘Residue’ refers to food (including the fibrous part of food) that is not fully digested by the gut, that makes up stool. A low residue diet increases the time food spends travelling through the gut, leaving a minimal amount of undigested food in the digestive tract resulting in fewer and smaller bowel movements. It is achieved by limiting fibre intake and certain foods that stimulate bowel contractions, making it easier for the gut to digest food and easing the passage of stools through the bowel.
This study will take place over 12 weeks when 40 adult patients (≥18 years) will be advised to follow a low-residue diet (less than 10g fibre per day). In addition to recording the change in average number of complete bowel movements per week at the start and end of the study (to better understand the effect of a low residue diet on gut symptoms in mitochondrial disease), we will monitor the safety of patients enrolled. We will also perform assessments of stool consistency, gut symptoms (including constipation), change in gut transit time (time for food to pass through the gut) and impact of disease symptoms on mental health and well-being. To ensure a well-balanced diet, vitamin and mineral supplements will also be prescribed.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0193
Date of REC Opinion
4 Jul 2017
REC opinion
Further Information Favourable Opinion