ArticleGastro hep advances2022
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.
Article in Gastro hep advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03388528 (Phase II Feasibility Study of the Efficacy and Acceptability of a Low Residue Diet in Adult Patients With Mitochondrial Disease), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Feasibility Study of the Efficacy and Acceptability of a Low Residue Diet in Adult Patients With Mitochondrial Disease
Who cites it
3 citing papers in PubMed.
- Advances in Primary Mitochondrial Diseases: Diagnosis, Natural History Studies and Clinical Trials.Genes · 2026Review
- Therapies for Mitochondrial Disease: Past, Present, and Future.Journal of inherited metabolic disease · 2025Review
- The interplay between mitochondria, the gut microbiome and metabolites and their therapeutic potential in primary mitochondrial disease.Frontiers in pharmacology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and Aims: Gastrointestinal (GI) dysmotility is a common and debilitating clinical manifestation in patients with mitochondrial DNA (mtDNA)-related disease with no curative and few effective symptomatic therapies. A low-residue diet (LRD) has been shown to be effective at reducing bowel urgency, pain, and distension in functional GI-related conditions. We assessed tolerability and effects of an LRD on bowel habits in patients with mtDNA-related disease. Methods: This was a 12-week single-arm pilot study in patients with genetically determined primary mtDNA-related disease, meeting the ROME III constipation criteria. The co-primary outcomes were tolerability of an LRD (<10 g fiber per day) assessed by food diaries and changes in stool frequency and consistency. The secondary outcomes included GI symptoms, disease burden, laxatives, physical activity levels, colonic transit time using radiopaque markers, gut microbiome (patients and controls), and metabolomics. The gut microbiome of the mtDNA-related disease patients was compared against controls for observational purpose only. Results: Twenty-eight patients were enrolled, and 24 completed the LRD intervention. The LRD was well tolerated with a mean fold change of -34% in dietary fiber (5.3 ± 10.4 grams) per day ( Conclusion: The LRD in patients with mtDNA-related mitochondrial disease and significant constipation is well tolerated and a promising treatment for alleviating GI symptoms. These positive findings should be confirmed in a randomized controlled trial.ClinicalTrials.gov Identifier: NCT03388528.
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