Low Residue Diet Study in Mitochondrial Disease
Ključne riječi
Sažetak
Opis
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.
Datumi
| Posljednja provjera: | 05/31/2019 |
| Prvo podneseno: | 10/26/2017 |
| Predviđena prijava predata: | 12/21/2017 |
| Prvo objavljeno: | 01/02/2018 |
| Zadnje ažuriranje poslato: | 10/08/2019 |
| Posljednje ažuriranje objavljeno: | 10/10/2019 |
| Stvarni datum početka studija: | 09/07/2017 |
| Procijenjeni datum primarnog završetka: | 02/06/2019 |
| Predviđeni datum završetka studije: | 02/06/2019 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: Treatment Group
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: Treatment Group 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: Treatment Group 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. |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 18 Years To 18 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | 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. |
Ishod
Primarne mjere ishoda
1. Assess tolerability of a Low Residue Diet (LRD) in mitochondrial patients [Change from baseline to 12 weeks]
2. Stool Frequency and consistency [Change from baseline to 12 weeks]
Sekundarne mjere ishoda
1. Gastrointestinal Dysmotility [Change from baseline to 12 weeks]
2. Disease Burden [Change from baseline to 12 weeks]
3. Gut Microbiome changes [Change from baseline to 12 weeks]
4. Gut Microbiome Comparison [Baseline only (prior to any intervention)]
5. Food Intake [Change from baseline to 12 weeks]
6. Colonic Transit Time [Change from baseline to 12 weeks]
7. Physical Activity [Change from baseline to 12 weeks]
8. Biochemistry [Change from baseline to 12 weeks]
9. Gastrointestinal Health [Change from baseline to 12 weeks]
10. Anthropometrics [Change from baseline to 12 weeks]
11. Physical Measurements [Change from baseline to 12 weeks]
12. Physical Dimensions [Change from baseline to 12 weeks]
13. Haematology [Change from baseline to 12 weeks]
