FibromyalgiaNCT04607278
The Effect of Probiotic and Prebiotic Use on Fibromyalgia Syndrome
A study testing Probiotic and Prebiotic in people with Fibromyalgia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to determine the effectiveness of probiotic and prebiotic treatments in patients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Probiotic and Prebiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Probiotic, Prebiotic, Placebo
- Keywords
- probiotics, prebiotics, fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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.
PrebioticDietary 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.
PlaceboDietary supplement
It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Oct 2019
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 8-week randomized, double-blind, parallel-group, placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Nur ASLAN ÇİN, PhD, Ankara University
- Investigators
- Didem Tuba Akcali, Prof Dr, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607278
- Sponsor's protocol ID
- 2019-08/375
- Status last verified
- Oct 2020
- First submitted
- 17 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Prebiotics as a Potential Treatment in Fibromyalgia Patients: A Randomized, Double-Blinded, Placebo-Controlled
- ClinicalTrials.gov ID
- NCT04607278
- Acronym / sponsor ID
- 2019-08/375
- Conditions
- Fibromyalgia
- Keywords
- probiotics, prebiotics, fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The 8-week randomized, double-blind, parallel-group, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticOral 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. |
| Prebiotic | Active comparator | Dietary Supplement: PrebioticThe 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIt was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticOral 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. | Dietary supplement | Probiotic |
| PrebioticThe 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. | Dietary supplement | Prebiotic |
| PlaceboIt was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups. | Dietary supplement | Placebo |
Primary outcome
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.
5 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 8 weeks
Beck Depression Inventory (BDI)
Time frame: 8 weeks
Beck Anxiety Inventory (BAI)
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks
SF-36 Quality of Life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didem Tuba Akcali, Prof Dr study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Prebiotic in people with Fibromyalgia, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.