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Completed

NCT Number: NCT05663060

Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice

Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humanitas Research Hospital

Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • Diagnosis of IBS according to Rome IV criteria
  • Mild to moderate disease, as measured by FBDSI
  • Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
  • Prescription of Bifidice, according to normal clinical practice
  • Informed consent expressed in written form

Exclusion criteria

  • Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
  • History of inflammatory bowel disease
  • Severe SII, measured by FBDSI
  • Active peptic ulcer
  • History of ischemic colitis
  • Active infectious enteritis
  • Diagnosed with hypo- or hyperthyroidism
  • Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
  • Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
  • Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort

Treatment and study plan

Probiotic Formula

Drug

Probiotic Formula

Primary outcomes

  1. Modification of teh intestinal microbiota

    Time frame: 12 months

    Analysis of faecal samples (Next Generation Sequencing analysis)

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice

Acronym: Bifidice01

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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