An interventional study of Low Residue Diet Intervention in Mitochondrial Diseases, sponsored by Newcastle University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-11.
Sponsored by Newcastle University · Not applicable, Interventional, and Treatment
Among 23 studies in Mitochondrial Diseases with a site in United Kingdom — 5 open to participants now, 5 under way, 1 of them phase 3. Mitochondrial Diseases · United Kingdom.
Among the 23 studies in Mitochondrial Diseases with a site in United Kingdom, this one is the 13th largest by enrollment of the 19 interventional ones that give a count, is one of 5 that started in 2017, is one of 5 with no phase, and was the 8th registered.
189 studies on the registry are indexed under Mitochondrial Diseases; 60 are open to participants now.
Browse Mitochondrial Diseases studies →5 of the 23 studies in Mitochondrial Diseases with a site in United Kingdom are open now. Recruiting first, the newest first:
Khondrion BV · Sites in United Kingdom, United States, Denmark and 4 more countries
Ages 18+
University College, London · Sites in United Kingdom
Ages 3–18
Newcastle-upon-Tyne Hospitals NHS Trust · Sites in United Kingdom
Women only
Salah Snouda · Sites in United Kingdom
Ages 18+
University College, London · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 40 Mitochondrial Diseases studies recruiting now, 20 (50%) set no upper age limit and 13 (33%) stop at 75 or younger; 19 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 7
First in 2015; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is close to the median of 35 across 114 interventional studies indexed under Mitochondrial Diseases.
Median enrollment 41 across the 19 interventional studies, 42 across the 4 observational. Of the 18 that completed or were terminated, 6 (33%) have results posted.
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14 of 23 have an industry lead sponsor. The 10 most frequent:
Newcastle University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.
Newcastle University has 2 studies filed under Mitochondrial Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Mitochondrial Diseases with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07606872Salah SnoudaValidation of the Snouda Metabolic Score for Phenotyping and Guiding Reversal in Type 2 Diabetes | 2026-12 |
| NCT04113447Newcastle-upon-Tyne Hospitals NHS TrustMitochondrial Donation: An 18 Month Outcome Study. | 2027-11-30 |
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Among the 23 studies in Mitochondrial Diseases with a site in United Kingdom, from their registry updates:
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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:
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.
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 including Cerebral Palsy, Multiple Sclerosis and Parkinson's Disease. Symptoms of intestinal dysmotility are often overlooked and frequently under-diagnosed in its early stages.
Indeed, in its most severe form, intestinal dysmotility may manifest as intestinal pseudo obstruction (IPO), characterised by a clinical picture suggestive of mechanical obstruction, exemplifying the need for early detection and management. To date, symptoms of intestinal dysmotility in slow transit time constipation, limited fluid and calorie intake, weight loss, and small intestinal bacterial overgrowth and in severe cases intestinal pseudo obstruction (2, 3). Moreover, the bacteria that reside within the gastrointestinal (GI) tract compete for nutrients, contributing to weight loss due to malabsorption of fat (4), protein and carbohydrates (5, 6), vitamin (7-11) and iron deficiency (12) are often evident. Further problems include poor digestion and absorption food, an impaired immune system, and an impaired drug absorption ability, all of which influence patient health, quality of life and increases National Health Service (NHS) costs.
A low residue diet is a form of low fibre diet (\<10g fibre per day) that is used to minimise symptoms of intestinal dysmotility by reducing faecal volume and bulk and hence bowel workload, ensuring limited bowel activity and colonic rest. It has been shown to be both tolerable and efficacious in other conditions associated with intestinal dysmotility; however, its role in patients with mitochondrial disease and intestinal dysmotility, is unknown.
This feasibility study proposes to systematically gather data on whether a low residue diet is tolerable and has an effect on intestinal dysmotility and health-related quality of life in in patients with mitochondrial disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients
Tolerability of the LRD will be assessed using food diaries
Time frame: 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
Time frame: Change from baseline to 12 weeks
Gastrointestinal Dysmotility
To determine the impact of a LRD on GI dysmotility symptoms using Assessment of Constipation-Symptom (PAC-SYM) questionnaire.
Time frame: Change from baseline to 12 weeks
Disease Burden
To determine the effect of LRD on patients Disease burden as assessed by the Newcastle Mitochondrial Disease Adult Scale (NMDAS) disease burden and quality of life. This is a questionnaire developed and validated by Wellcome Centre for Mitochondrial Research, Newcastle upon Tyne. This is a scored questionnaire that encompasses questions on patient's disease burden encompassing: Current Function: Vision with usual glasses or contact lenses; Migraine Headaches; Seizures; Stroke like episodes; Encephalopathic Episodes; Gastro-intestinal symptoms; Diabetes mellitus; Respiratory muscle weakness and Cardiovascular system. Current Clinical Assessment: Visual acuity; Ptosis; Chronic Progressive External Ophthalmoplegia; Dysphonia/Dysarthria; Myopathy; Cerebellar ataxia; Neuropathy; Pyramidal Involvement; Extrapyramidal and Cogitation. These are all included under the NMDAS questionnaire and are used by clinical care teams to help determine patient's current disease burden.
Time frame: Change from baseline to 12 weeks
Gut Microbiome changes
Assess effect of a LRD on gut metagenomics
Time frame: Change from baseline to 12 weeks
Gut Microbiome Comparison
A comparison of the gut microbiome composition and diversity assessed by sequencing, between healthy controls and mitochondrial patients prior to the LRD intervention.
Time frame: Baseline only (prior to any intervention)
Food Intake
To assess the impact of a LRD on food intake (Food Frequency Questionnaire (FFQ) will be completed for 72 hours (1 day over the weekend and 2 days during the week).
Time frame: Change from baseline to 12 weeks
Colonic Transit Time
Colonic transit time (CTT) as assessed by plain abdominal X-ray following ingestion of oral colonic marker ingestion.
Time frame: Change from baseline to 12 weeks
Physical Activity
Activity level (GeneActiv 7-10 days).
Time frame: Change from baseline to 12 weeks
Biochemistry
The Biochemistry department in the Royal Victoria Infirmary in Newcastle upon Tyne will be provided with whole blood. Using this they will measures liver enzymes (alanine transaminase, aspartate aminotransferase, gamma-glutamyl transpeptide), alkaline phosphatase, albumin, bilirubin, lipid profile and C-Peptide tests.
Time frame: Change from baseline to 12 weeks
Gastrointestinal Health
To determine the impact of a LRD on patient GI symptoms using the Gastrointestinal Quality-of-Life Index. This includes defecation characteristics including laxative use and reported abdominal symptoms categorized as pain or cramps and bloating or flatulence according to five classifications (1, none; 2, mild; 3, moderate; 4, severe; or 5, very severe).
Time frame: Change from baseline to 12 weeks
Anthropometrics
Weight (kg)
Time frame: Change from baseline to 12 weeks
Physical Measurements
Body Mass Index
Time frame: Change from baseline to 12 weeks
Physical Dimensions
Waist to hip ratio (inches)
Time frame: Change from baseline to 12 weeks
Haematology
The Haematology department in the Royal Victoria Infirmary in Newcastle upon Tyne will be provided with whole blood. Using this they will provide a Full blood count, Haematocrit screen, Ferritin, Vitamin B12, HbA1c and Folate.
Time frame: Change from baseline to 12 weeks
Plan to share: No — Patients will be anonymised, and only raw outcome data will be shared in conjunction with collaborators of the Wellcome Centre for Mitochondrial Research .
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Feb 2019, 16 months.
Of 26 interventional studies with no phase under Mitochondrial Diseases, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 60. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Newcastle University