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The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Probiotic
Prebiotic
Placebo
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring probiotics, prebiotics, fibromyalgia

Eligibility Criteria

21 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women aged 20-65 years.
  2. Signature of informed consent by the patient.
  3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
  4. Participants should be diagnosed with fibromyalgia at least 1 year ago.

Exclusion Criteria:

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

Sites / Locations

  • Ankara University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Prebiotic

Placebo

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale (VAS)
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.
Beck Depression Inventory (BDI)
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.
Beck Anxiety Inventory (BAI)
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
Pittsburgh Sleep Quality Index (PSQI)
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
SF-36 Quality of Life
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).

Full Information

First Posted
October 17, 2020
Last Updated
October 28, 2020
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT04607278
Brief Title
The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
Official Title
Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
probiotics, prebiotics, fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 8-week randomized, double-blind, parallel-group, placebo-controlled study
Masking
ParticipantInvestigator
Masking Description
Patients and investigators are double-blinded
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Arm Title
Prebiotic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
8 weeks
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
8 weeks
Title
Beck Anxiety Inventory (BAI)
Description
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
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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
Time Frame
8 weeks
Title
SF-36 Quality of Life
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didem Tuba Akcali, Prof Dr
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University
City
Ankara
State/Province
Kecıoren
ZIP/Postal Code
06170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome

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