Gut Microbiome Changes with Osteopathic Treatment of Constipation in Parkinson's Disease: A Pilot Study.
Jayme D Mancini, Sheldon Yao, Luis R Martinez...
https://pubmed.ncbi.nlm.nih.gov/33899052Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07176078
Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial
Led by Universitair Ziekenhuis Brussel · Updated on 2026-04-17
96
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with irritable bowel syndrome (IBS) and fibromyalgia to see if adding osteopathic care to a flexible FODMAP diet improves IBS symptoms. The trial aims to find out if real osteopathic care reduces symptom severity and other issues like pain, quality of life, anxiety, fatigue, and work productivity better than sham care. It will also look at diet adherence, safety, and whether effects last up to six months after treatment, while exploring whether personal factors can predict response to osteopathic care. Participants will be randomly assigned to receive either four weekly sessions of personalized osteopathic care or sham osteopathic care, both combined with a 4-week online flexi-FODMAP diet program. Osteopathic care includes a medical history, examination, treatment, and advice tailored by an osteopath using various manual techniques. Sham care mimics examination and light touch without therapeutic intent. The diet is a less restrictive version of the FODMAP elimination diet, delivered through a customized online platform. During the study, participants will visit the clinic for four treatment sessions and complete online assessments before and after intervention, as well as at 3 and 6 months follow-up. They will provide stool samples and keep food and stool diaries at these times. Researchers will measure changes in IBS symptom severity, pain, fatigue, quality of life, anxiety, depression, sleep quality, stress, work productivity, gut microbiota, diet adherence, and patient satisfaction. The study will monitor safety and tolerability of osteopathic care throughout the trial period.
CONDITIONS
Brief Title
Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with irritable bowel syndrome (IBS) by a medical doctor using Rome IV criteria
- IBS Symptom Severity Score (IBS-SSS) of 175 or higher indicating moderate to severe symptoms
- Diagnosed with fibromyalgia or meeting the 2016 American College of Rheumatology criteria for fibromyalgia, including specific pain and symptom severity scores
- Willing to maintain usual probiotic or lactose-reduced diet intake unless advised to reduce lactose further
- Using stable doses of IBS medications including antidepressants for at least 2-3 months prior
- Willing to adjust dietary habits to follow the study diet
You will not qualify if you...
- Having other gastrointestinal disorders such as inflammatory bowel disease or celiac disease
- Having diseases affecting gastrointestinal function including history of bariatric surgery
- Having allergies or food hypersensitivity except lactose intolerance
- Having major dietary restrictions or food allergies
- Being pregnant or planning pregnancy during the next seven months
- Having a body mass index (BMI) less than 18 kg/m²
- Having received osteopathic care for IBS or currently following a FODMAP diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - 4 weeks
Participants follow a 4-week flexi-FODMAP diet delivered online and receive either 4 weekly consultations of person-centered osteopathic care or sham osteopathic care mimicking clinical examination and treatment.
4 weekly visits (in-person) for osteopathic or sham osteopathic care; diet instructions provided online
Follow-up
Duration - 6 months
Participants are monitored for changes in symptoms, quality of life, and other health measures up to 6 months after the end of intervention.
Assessments at 3 months and 6 months post-intervention (may be remote or in-person)
Trial Site Locations
Total: 1 location
1
Vrije Universiteit Brussel
Brussels, Brussels Capital, Belgium, 1090
Actively Recruiting
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Research Team
E
Evert Zinzen, PhD
I
Ishtiaq Ahmed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effectiveness of Osteopathic Manipulative Treatment in Adults with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.
Francesca Buffone, Andrea Gianmaria Tarantino, Federico Belloni...
https://pubmed.ncbi.nlm.nih.gov/37685480Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial.
Thu-Van Attali, Michel Bouchoucha, Robert Benamouzig
https://pubmed.ncbi.nlm.nih.gov/23981319Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study.
Blanche-Maëlle Florance, Gregory Frin, Raffaella Dainese...
https://pubmed.ncbi.nlm.nih.gov/22546751