The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

NCT04607278 | Completed

• 1 other identifier: 2019-08/375
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.

Conditions

Fibromyalgia

Keywords

probiotics; prebiotics; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ)

  Fibromyalgia Impact Questionnaire (FIQ) form is a evaluate the functional status of the patients. In this scale, 10 different features are measured: physical function, well-being, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The scale is scored range 0-100. Low scores indicated recovery except for the feeling of well-being.

  8 weeks

Secondary Outcomes (5)

• Visual Analogue Scale (VAS)

  8 weeks

• Beck Depression Inventory (BDI)

  8 weeks

• Beck Anxiety Inventory (BAI)

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  8 weeks

• SF-36 Quality of Life

  8 weeks

Study Arms (3)

Probiotic

EXPERIMENTAL

Oral probiotic supplementation (Pro-Probiotic) was provided by iHealth; Cromwell, USA. Each sachet included a 1×1010 CFUs dose of four viable microbial cell preparation strains: there are two strains of lactobacillus genus (Lactobacillus acidophillus L1 (2.9×109) and Lactobacillus rhamnosus liobif (2.9×109)), Bifidobacterium longum (2.9×109) and Saccharomyces boulardii (1.3×109). Each participant took a total daily dose of 4×1010 CFUs.

Dietary Supplement: Probiotic

Prebiotic

ACTIVE COMPARATOR

The prebiotic (Inulin) was made up of inulin from the chicory plant and provided by the Fibrelle (Belgium) company. Five grams packs were given to the participants in boxes. Each participant was requested to take a total daily 10 g dose.

Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Oral probiotic supplementation was provided by iHealth; Cromwell, USA. Each sachet included a 1×1010 CFUs dose of four viable microbial cell preparation strains: there are two strains of lactobacillus genus (Lactobacillus acidophillus L1 (2.9×109) and Lactobacillus rhamnosus liobif (2.9×109)), Bifidobacterium longum (2.9×109) and Saccharomyces boulardii (1.3×109). Each participant took a total daily dose of 4×1010 CFUs.

Probiotic

Prebiotic DIETARY_SUPPLEMENT

The prebiotic was made up of inulin from the chicory plant and provided by the Fibrelle (Belgium) company. Five grams packs were given to the participants in boxes. Each participant was requested to take a total daily 10 g dose.

Prebiotic

Placebo DIETARY_SUPPLEMENT

It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.

Placebo

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 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.
• Participants should be diagnosed with fibromyalgia at least 1 year ago.

You may not qualify if:

• using of antibiotic and nutritional supplements
• being pregnant or breastfeeding
• the presence of any allergies
• being involved in any medical or psychological research
• the presence of severe gastrointestinal diseases
• psychiatric illness other than depression and anxiety.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Kecıoren, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Probiotics; Prebiotics

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; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Didem Tuba Akcali, Prof Dr

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and investigators are double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant in Department of Nutrition and Dietetics

Model Details: The 8-week randomized, double-blind, parallel-group, placebo-controlled study

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: October 29, 2020
• Study Start: October 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)