Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome

NCT07176078 | Recruiting

• 1 other identifier: 25153_POISE-IBS-RCT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care. The main questions it aims to answer are: Does osteopathic care reduce IBS symptom severity more than sham osteopathic care? Does osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care? Do participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention? Can pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care? What adverse effects occur with osteopathic care compared to sham care? Participants will: Visit the osteopathy clinic to receive four sessions of real or sham osteopathic care Complete online assessments before and after the intervention, and at 3- and 6-months post-intervention Provide stool samples before and after the four osteopathic or sham sessions Keep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention

Conditions

Irritable Bowel Syndrome (IBS); Fibromyalgia (FM)

Keywords

Osteopathic Care; Irritable Bowel Syndrome; Fibromyalgia; FODMAP Diet

Outcome Measures

Primary Outcomes (1)

• Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

  The IBS Symptom Severity Score (IBS-SSS) will be utilized to evaluate the severity of IBS symptoms. This scale provides an overall score ranging from 0 to 500, with higher scores indicating greater symptom severity. The questionnaire includes the following components: intensity and frequency of abdominal pain, abdominal distension, dissatisfaction with bowel habits, and the overall impact of IBS on daily life ("life interference"). Scores are categorized as follows: 75-175 indicates mild severity, 175-300 represents moderate severity, and 300 or above reflects severe symptoms. The IBS-SSS considered a valid and reliable scale, with a Cronbach's Alpha = 0.80.

  Baseline and after 4 weeks (post-intervention)

Secondary Outcomes (14)

• Change in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

  Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention

• 3 day dietary dairy

  Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention

• Stool Diary

  Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention

• Change in Pain intensity

  Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention

• Change in Fatigue severity

  Baseline, after 4 weeks (post-intervention), 3 months after the end of intervention, and 6 months after the end of intervention

Study Arms (2)

Osteopathic care + flexi FODMAP diet

EXPERIMENTAL

Other: Osteopathic care; Behavioral: Flexi-FODMAP Diet

Sham osteopathic care + flexi FODMAP diet

SHAM COMPARATOR

Other: Sham Osteopathic care; Behavioral: Flexi-FODMAP Diet

Interventions

Osteopathic care OTHER

Participants allocated to the osteopathic care group will receive 4 weekly consultations of person-centered osteopathic care. Each consultation will last approximately 45 minutes and consist of a careful medical history, a clinical examination, treatment, and advice (e.g. exercise, dietary, lifestyle). The osteopathic treatment protocol could be labeled as 'custom tailored': the determination of the treatment was left to the clinical judgment of the osteopath, meaning that no predefined, standardized osteopathic protocol would be implemented. Standard osteopathic techniques (Glossary of Osteopathic Terminology) can be applied, including diagnostic techniques (e.g. observation, neurological tests, palpation, and motion testing) and therapeutic direct (e.g. high-velocity low-amplitude, muscle energy), indirect techniques (e.g. strain counter strain, balanced ligamentous tension, balanced membranous tension), or combined techniques.

Osteopathic care + flexi FODMAP diet

Sham Osteopathic care OTHER

For this trial, sham intervention will mimic the osteopathic care according to the "touch equality assumption". Therefore, it mimics a clinical examination and treatment. The sham clinical evaluation involves a full evaluation of the position and mobility of the spine.This screening of the patient will be performed using conventional osteopathic manual tests, without any intention to make a diagnosis. Sham treatment will involve light manual contact, with the subject lying supine on the treatment table.

Sham osteopathic care + flexi FODMAP diet

Flexi-FODMAP Diet BEHAVIORAL

In addition to the real or sham osteopathic care, all participants will follow a 4-week flexi-FODMAP diet delivered online. Participants will receive structured dietary instructions via a customized online platform, based on the NHS Gentle-FODMAP diet guidelines and informed by expert input from dieticians. This modified "FODMAP-gentle" approach involves a targeted, less restrictive elimination of selected high-FODMAP foods.

Osteopathic care + flexi FODMAP diet; Sham osteopathic care + flexi FODMAP diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study includes participants who meet the following criteria:
• are over 18 years old;
• have a diagnosis of IBS by a medical doctor according to the Rome IV criteria and have an IBS-SSS score of ≥175 (indicating moderate to severe IBS symptoms);
• have a medical diagnosis of fibromyalgia or meet the 2016 American College of Rheumatology criteria, characterized by chronic (≥3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of ≥7 with a Symptom Severity Score of ≥5, or a WPI score of 4-6 with a Symptom Severity Score ≥9 on the Widespread Pain Index).

You may not qualify if:

• This study excludes participants who meet any of the following criteria:
• have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;
• have diseases affecting gastrointestinal function, including a history of bariatric surgery;
• have allergies or food hypersensitivity (other than lactose intolerance);
• have any major dietary restrictions or food allergies;
• are pregnant or planning pregnancy during the trial (within the next seven months);
• have a BMI ≤18 kg/m²; or 7) have received osteopathic care for IBS and/or are already following the FODMAP dietary intervention.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (4)

• Mancini JD, Yao S, Martinez LR, Shakil H, Li TS. Gut Microbiome Changes with Osteopathic Treatment of Constipation in Parkinson's Disease: A Pilot Study. Neurology (ECronicon). 2021 Feb;13(2):19-33. Epub 2021 Jan 30.

  PMID: 33899052 BACKGROUND

• Buffone F, Tarantino AG, Belloni F, Spadafora A, Bolzoni G, Bruini I, Bergna A, Vismara L. Effectiveness of Osteopathic Manipulative Treatment in Adults with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Aug 31;11(17):2442. doi: 10.3390/healthcare11172442.

  PMID: 37685480 BACKGROUND

• Attali TV, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013 Dec;14(12):654-61. doi: 10.1111/1751-2980.12098.

  PMID: 23981319 BACKGROUND

• Florance BM, Frin G, Dainese R, Nebot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hebuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):944-9. doi: 10.1097/MEG.0b013e3283543eb7.

  PMID: 22546751 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Fibromyalgia

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Evert Zinzen, PhD

CONTACT

+32-2-629.27.17; Evert.Zinzen@vub.be

Ishtiaq Ahmed

CONTACT

ishtiaq.ahmed@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)