FibromyalgiaNCT02642289
Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
A study testing Lactobacillus acidophilus and Lactobacillus Rhamnosus GG ® in people with Fibromyalgia, run by Pablo Román López at 1 site in Spain.
Trial summary
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Lactobacillus acidophilus and Lactobacillus Rhamnosus GG ®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2015to Feb 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia syndrome diagnosis.
- No treatment with antibiotic.
- More than a year of diagnosis
- Agreement to participate in the study.
Who cannot join
- Severe physical disability.
- Malignancy.
- Pregnancy
- Psychiatric illnesses (eg, schizophrenia or substance abuse).
- Medication usage other than as-needed analgesics (excluding long-term narcotics).
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
Read the detailed description
Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.
The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Lactobacillus acidophilus, Lactobacillus Rhamnosus GG ®, Placebo
- Keywords
- Probiotics
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilusDietary supplement
Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
Lactobacillus Rhamnosus GG ®Dietary supplement
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"
PlaceboOther
Innocuous substance
| Study group | Role | What they receive |
|---|---|---|
| Probiotic1: Lactobacillus acidophilus | Experimental | Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions) Receives: Dietary Supplement: Lactobacillus acidophilus |
| Placebo | Placebo comparator | Inactivate substance Receives: Other: Placebo |
| Probiotic2: Lactobacillus Rhamnosus GG ® | Experimental | Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions) Receives: Dietary Supplement: Lactobacillus Rhamnosus GG ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Scores on Working memory and attentional control
Corsi task
Measured: Time Frame: At baseline and 8 weeks
Secondary outcomes (12)
Change Scores on Body Composition
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Measured: Time Frame: At baseline and 8 weeks
Changes Scores on Cholinergic response indicators (%)
Measured: Time Frame: At baseline and 8 weeks
Changes Scores on Heart rate variability.
Measured: Time Frame: At baseline and 8 weeks
Changes Scores on Valsalva ratio. K30/15.
Measured: Time Frame: At baseline and 8 weeks
Changes Scores on Systemic vascular resistance.
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Pain
Index of Widespread Pain and Symptom Severity
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Sleep Quality
Pittsburgh Sleep Quality Index Questionnaire (PSQI)
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Quality of Life
The assessment of Quality of Life (SF-36)
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Depression
The Beck inventory for depression
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Stress
Determination of cortisol in urine
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Anxiety
The State-Trait Anxiety Inventory (STAI)
Measured: Time Frame: At baseline and 8 weeks
Change Scores on Impulsivity
The Two-choice task
Measured: Time Frame: At baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pablo Román López
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo Román López, Universidad de Almeria
- Investigators
- Angeles Fernandez, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642289
- Sponsor's protocol ID
- UAL-270415
- Status last verified
- Mar 2016
- First submitted
- 21 Dec 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02642289
- Acronym / sponsor ID
- UAL-270415
- Conditions
- Fibromyalgia
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pablo Román LópezUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- 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.
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
Detailed description
Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.
The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic1: Lactobacillus acidophilus | Experimental | Dietary Supplement: Lactobacillus acidophilusDietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions) |
| Placebo | Placebo comparator | Other: PlaceboInactivate substance |
| Probiotic2: Lactobacillus Rhamnosus GG ® | Experimental | Dietary Supplement: Lactobacillus Rhamnosus GG ®Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fibromyalgia syndrome diagnosis.
- No treatment with antibiotic.
- More than a year of diagnosis
- Agreement to participate in the study.
Key exclusion criteria (5 listed)
- Severe physical disability.
- Malignancy.
- Pregnancy
- Psychiatric illnesses (eg, schizophrenia or substance abuse).
- Medication usage other than as-needed analgesics (excluding long-term narcotics).
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 |
|---|---|---|
| Lactobacillus acidophilusProbiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L." | Dietary supplement | Probiotic1: Lactobacillus acidophilus |
| Lactobacillus Rhamnosus GG ®Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia" | Dietary supplement | Probiotic2: Lactobacillus Rhamnosus GG ® |
| PlaceboInnocuous substance | Other | Placebo |
Primary outcome
Change Scores on Working memory and attentional control
Time frame: Time Frame: At baseline and 8 weeks
Corsi task
12 secondary outcomes
Change Scores on Body Composition
Time frame: Time Frame: At baseline and 8 weeks
Changes Scores on Cholinergic response indicators (%)
Time frame: Time Frame: At baseline and 8 weeks
Changes Scores on Heart rate variability.
Time frame: Time Frame: At baseline and 8 weeks
Changes Scores on Valsalva ratio. K30/15.
Time frame: Time Frame: At baseline and 8 weeks
Changes Scores on Systemic vascular resistance.
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Pain
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Sleep Quality
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Quality of Life
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Depression
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Stress
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Anxiety
Time frame: Time Frame: At baseline and 8 weeks
Change Scores on Impulsivity
Time frame: Time Frame: At baseline and 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 14 Mar 2016.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Angeles Fernandez, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus acidophilus and Lactobacillus Rhamnosus GG ® in people with Fibromyalgia, run by Pablo Román López at 1 site in Spain.
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 5 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 14 Mar 2016. 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 Spain. 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?
Change Scores on Working memory and attentional control (time frame: Time Frame: At baseline and 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 14 Mar 2016.