- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04607278
The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
October 28, 2020 updated by: Nazlı Nur ASLAN ÇİN, PhD, Ankara University
Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fifty-three, fibromyalgia syndrome participants were randomized to receive either: 1) probiotic 4×1010 CFUs per day 2) 10 g dose prebiotic (inulin) per day or 3) placebo for 8 wk.
Fibromyalgia Impact Questionnaire (FIQ), Visual Analogical Pain Scale (VAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburg Sleep Quality Index (PSQI) and quality of life (SF-36) were measured during the baseline, 4 weeks and 8 weeks intervention phases.
Finally, the adverse effects will be evaluated.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kecıoren
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Ankara, Kecıoren, Turkey, 06170
- Ankara University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
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.
|
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.
|
Active Comparator: Prebiotic
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.
|
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.
|
Placebo Comparator: Placebo
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium).
The prescription was similar to probiotics or prebiotics groups.
|
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium).
The prescription was similar to probiotics or prebiotics groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: 8 weeks
|
VAS was used to question the severity of the whole body pain in patients.
On a 10 cm long line, "0" score indicates no pain, while "10" score indicates the most severe pain.
|
8 weeks
|
Beck Depression Inventory (BDI)
Time Frame: 8 weeks
|
Depressive symptoms are assessed using the Beck Depression Inventory (BDI) which includes 21 questions with four possible answers sorted according to symptom severity.
A score of 0-3 is given for each question, and the total score from the scale is ranked between 0-63.
If the score increases, it indicates that the severity of depressive symptoms increases.
|
8 weeks
|
Beck Anxiety Inventory (BAI)
Time Frame: 8 weeks
|
Anxiety levels were measured with the 21-item Beck Anxiety Inventory (BAI).
Participants were asked to report the intensity and frequency of their feeling of anxiety using a Likert-like scale from 0 (not at all) to 3 (it bothered me a lot).
If the total score increases, it increases the tendency of the individual to anxiety
|
8 weeks
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 weeks
|
Pittsburgh Sleep Quality Index questionnaire (PSQI) is used as a subjective measure of sleep quality and disturbances of the patient's sleep.
The PSQI is a 19-item self-reported questionnaire grouped into seven score components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction).
The PSQI assess behavior using Likert scales from 0 to 3, and five questions rated by the bed partner, if applicable.
The PSQI yields a score from 0 (good quality) to 21 (poor quality).
Global Scores >5 indicate significant sleep complaints.
Those with a score of ≤5 is classified as good sleepers
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8 weeks
|
SF-36 Quality of Life
Time Frame: 8 weeks
|
SF-36 can be used for many purposes, consists of 36 questions, determines the health status of the healthy individuals or patients.
The 36 multi-item scale of the short form SF-36 covers 8 aspects of physical and mental health: (1) Physical functioning (PF); (2) Role physical (RF); (3).
Bodily pain (BP); (4) General health (GH); (5) Vitality (VT); (6) Social functioning (SF); (7) Role emotional (RE); (8) Mental health (MH).
Domains 1 to 4 of the questionnaire deal with physical aspects, while domains 5 to 8 measure psychological features.
For each parameter, scores is coded, summed and transformed to a scale from 0 (the worst possible condition) to 100 (the best possible condition).
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Didem Tuba Akcali, Prof Dr, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
October 17, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 29, 2020
Study Record Updates
Last Update Posted (Actual)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 28, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-08/375
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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