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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Combined Exercise Program + A specific nutritional plan for individuals with IBS for Fibromyalgia

Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness.

Official registry: https://clinicaltrials.gov/study/NCT06923800 · Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · enrollment listed as 30

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Combined Exercise Program + A specific nutritional plan for individuals with IBS, or Aerobic Exercise + A specific nutritional plan for individuals with IBS. The registry lists allocation as randomized. Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties.

They plan to enroll about 30 people at Castellana Grotte. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study

Interventions: Combined Exercise Program + A specific nutritional plan for individuals with IBS, Aerobic Exercise + A specific nutritional plan for individuals with IBS

Primary outcome (registry wording): Fibromyalgia symptom assesment

Who it is for (from inclusion criteria)

  • Ages 30 Years to 65 Years
  • Women only
  • Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS
  • Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) \> 175 (indicating moderate to severe IBS symptoms)
  • Men and women aged between 30 and 65 years
  • Body Mass Index (body-mass index (BMI)) between 18.5 and 34.9

Public study contact (from the registry)

Antonella Bianco

+390804994653

antonella.bianco@irccsdebellis.it

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06923800 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06923800?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06923800?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary