Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)

NCT04435886 | Unknown

• 1 other identifier: FIBRO.PROB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of fibromyalgia symptoms in individuals diagnosed. The primary outcome measure will be the progression and treatment of fibromyalgia, defined as a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual medical treatment. Finally adverse effects will be evaluated. The study will have two arms: one arm including a probiotic preparation and a placebo arm.

Conditions

Fibromyalgia

Keywords

Probiotic; Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• Score on the Fibromyalgia Impact Questionnaire (FIQ)

  Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4

  4-week

• Score on the Fibromyalgia Impact Questionnaire (FIQ)

  Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 8

  8-week

• Score on the Fibromyalgia Impact Questionnaire (FIQ)

  Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 12.

  12-week

Secondary Outcomes (13)

• Score on the Hospital Anxiety and Depression Scale (HAD)

  4 weeks

• Score on the Hospital Anxiety and Depression Scale (HAD)

  8 weeks

• Score on the Hospital Anxiety and Depression Scale (HAD)

  12 weeks

• Visual Analogical Pain Scale (VAS) Score

  12 weeks

• Changes to a patient's usual medical treatment for fibromyalgia

  4 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

A multi-strain probiotic

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Identical placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic mixture with maltodextrin as a carrier.

Probiotic group

Placebo DIETARY_SUPPLEMENT

Placebo comparator with maltodextrin as a carrier.

Placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20 - 65 years.
• Signature of informed consent by the patient.
• Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia

You may not qualify if:

• \. Women who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

Sponsors & Collaborators

• Biopolis S.L.: lead

Study Sites (1)

Hospital Universitario de Vinalopó

Elche, Alicante, 03293, Spain

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

María Empar Chenoll, PhD

CONTACT

+34 673 53 53 44; maria.chenoll@adm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 12-week randomized, double-blind, parallel-group, placebo-controlled study

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: March 2, 2020
• Primary Completion: February 2, 2021
• Study Completion: May 2, 2021
• Last Updated: July 10, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)