Mitochondrial DiseasesLRDNCT03388528
Low Residue Diet Study in Mitochondrial Disease
A study testing Low Residue Diet Intervention in people with Mitochondrial Diseases, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitochondrial Diseases
- What is being tested?
- Low Residue Diet Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Sep 2017to 7 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Grainne Gorman
Newcastle upon Tyne, Tyne and Wear, NE2 4HH
About this study
Official title: Phase II Feasibility Study of the Efficacy and Acceptability of a Low Residue Diet in Adult Patients With Mitochondrial Disease
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:
Read more
- 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.
Read the 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 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.
- Conditions
- Mitochondrial Diseases
- Being tested
- Low Residue Diet Intervention
- Keywords
- Dysmotility, Microbiome, Transit Time, Gastrointestinal
- Medical subject headings
- Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Residue Diet InterventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Low Residue Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients
Tolerability of the LRD will be assessed using food diaries
Measured: 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
Measured: Change from baseline to 12 weeks
Secondary outcomes (13)
Gastrointestinal Dysmotility
To determine the impact of a LRD on GI dysmotility symptoms using Assessment of Constipation-Symptom (PAC-SYM) questionnaire.
Measured: 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.
Measured: Change from baseline to 12 weeks
Gut Microbiome changes
Assess effect of a LRD on gut metagenomics
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Change from baseline to 12 weeks
Physical Activity
Activity level (GeneActiv 7-10 days).
Measured: 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.
Measured: 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).
Measured: Change from baseline to 12 weeks
Anthropometrics
Weight (kg)
Measured: Change from baseline to 12 weeks
Physical Measurements
Body Mass Index
Measured: Change from baseline to 12 weeks
Physical Dimensions
Waist to hip ratio (inches)
Measured: 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.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start8 Sep 2017
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Grainne S Gorman, MD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388528
- Sponsor's protocol ID
- 17/NE/0193
- Acronym
- LRD
- Status last verified
- Jun 2019
- First submitted
- 27 Oct 2017
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients will be anonymised, and only raw outcome data will be shared in conjunction with collaborators of the Wellcome Centre for Mitochondrial Research .
Publications
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.
PubMed 39132075
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Feasibility Study of the Efficacy and Acceptability of a Low Residue Diet in Adult Patients With Mitochondrial Disease
- ClinicalTrials.gov ID
- NCT03388528
- Acronym / sponsor ID
- LRD / 17/NE/0193
- Conditions
- Mitochondrial Diseases
- Keywords
- Dysmotility, Microbiome, Transit Time, Gastrointestinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Dietary Supplement: Low Residue Diet InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Residue Diet InterventionAll 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. | Dietary supplement | Treatment Group |
Primary outcome
Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients
Time frame: Change from baseline to 12 weeks
Tolerability of the LRD will be assessed using food diaries
Stool Frequency and consistency
Time frame: Change from baseline to 12 weeks
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
13 secondary outcomes
Gastrointestinal Dysmotility
Time frame: Change from baseline to 12 weeks
Disease Burden
Time frame: Change from baseline to 12 weeks
Gut Microbiome changes
Time frame: Change from baseline to 12 weeks
Gut Microbiome Comparison
Time frame: Baseline only (prior to any intervention)
Food Intake
Time frame: Change from baseline to 12 weeks
Colonic Transit Time
Time frame: Change from baseline to 12 weeks
Physical Activity
Time frame: Change from baseline to 12 weeks
Biochemistry
Time frame: Change from baseline to 12 weeks
Gastrointestinal Health
Time frame: Change from baseline to 12 weeks
Anthropometrics
Time frame: Change from baseline to 12 weeks
Physical Measurements
Time frame: Change from baseline to 12 weeks
Physical Dimensions
Time frame: Change from baseline to 12 weeks
Haematology
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Derived from this study: PubMed 39132075Houghton 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.
- Individual participant dataSharing planned: No. Patients will be anonymised, and only raw outcome data will be shared in conjunction with collaborators of the Wellcome Centre for Mitochondrial Research .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grainne S Gorman, MD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Residue Diet Intervention in people with Mitochondrial Diseases, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients (time frame: Change from baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.