EndometriosisNCT07149519
Impact of Dietary Guidance and Probiotics in the Treatment of Endometriosis and Irritable Bowel Syndrome in Women
A study testing probiotics - Lactobacillus spp in people with Endometriosis and Bowels Irritable, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Endometriosis, Bowels Irritable
- What is being tested?
- probiotics - Lactobacillus spp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2025to 15 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women between 18 and 50 years of age who wish to participate in the clinical trial;
- Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms;
- Participating exclusively in this clinical trial during the study period;
- Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP
Who cannot join
- Chronic, severe, or uncompensated clinical conditions, such as: malnutrition (BMI <18); insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension; lung disease such as asthma or other chronic obstructive pulmonary disease; hematologic and liver diseases; advanced-stage chronic kidney disease (grades 3, 4, and 5); metabolic disorders; and immunosuppression;
- Clinical conditions of the gastrointestinal tract that cause IBS-like symptoms, such as: inflammatory bowel disease (Chron's disease, ulcerative colitis), microscopic colitis, celiac disease, and lactose intolerance;
- Endometriosis requiring surgical treatment during the study period;
- Severe eating disorders, such as: bulimia, anorexia nervosa, and binge-eating disorder;
- Chronic use of any medication with potential interaction with probiotics, the intestinal microbiota, or the natural progression of the disease in the last 6 months (such as probiotics, antibiotics, antifungals, antihistamines, digestive medications, or treatments for constipation or diarrhea);
- Patients who already consume healthy foods or are on a restrictive diet more than four days a week, which may affect the evaluation results;
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- Patients whose stool protopastological examination is altered;
- Inability to use oral medication;
- Pregnancy or lactation;
- History of alcohol or drug dependence;
- Smoking in the last three years;
- Inability to cooperate with investigators due to cognitive impairment or mental state.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Letícia Ferracini Lenharo Hayashi
Catanduva, São Paulo, 15800-050
leticia hayashi, 55.17981197799, le.lenharo@usp.br
About this study
Official title: Impact of Dietary Guidance and Probiotics in the Treatment of Chronic Pelvic Pain Secondary to Endometriosis and Irritable Bowel Syndrome in Women: A Randomized, Double-Blind Clinical Trial
Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities.
Read the detailed description
Endometriosis (EDT) is a chronic, inflammatory, hormone-dependent disease that induces cellular adhesion and proliferation, stimulates vascularization, and disrupts protective immune responses. In its intestinal form, endometriosis can lead to abdominal pain, dyschezia, and both cyclic and non-cyclic changes in bowel habits. Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS, which is a disorder characterized by brain-gut interactions and inflammation, presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Anti-inflammatory diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. Given the already documented alteration of the gut microbiota and the female reproductive tract, and their dysbiosis associated with the development of EDT and IBS, the investigators are encouraged to further explore the connection between them. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities. By doing so, the investigators aim to underscore the significance of exploring non-pharmacological treatments and to provide new insights for advancing the understanding and management of endometriosis.
- Conditions
- Endometriosis, Bowels Irritable
- Being tested
- probiotics - Lactobacillus spp
- Keywords
- dietary, probiotics, endometriosis, bowel irritable syndrome, pelvic chronic pain
- Medical subject headings
- Endometriosis, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics - Lactobacillus sppDietary supplement
Also called Low FODMAPs dietary
Group 1: Specific dietary guidance (low-FODMAP diet ) combined with placebo Group 2: Specific dietary guidance (low-FODMAP diet ) combined with probiotic Group 3: Control - Exclusive habitual diet After the 12-week period, we will evaluate the clinical improvement response of pelvic pain
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Specific dietary guidance associated with placebo. | Placebo comparator | Patients in this group will receive, within 24 hours of randomization, guidance on a low-FODMAP diet, which must be followed for 12 weeks (120 days), and placebo. Receives: Dietary Supplement: probiotics - Lactobacillus spp |
| Arm 2: Specific dietary guidance combined with probiotics. | Experimental | Patients in this group will receive, within 24 hours of randomization, the same low-FODMAP diet guidance combined with probiotics (Lactobacillus and L. gasseri combinations) administered orally once daily for 12 weeks. Receives: Dietary Supplement: probiotics - Lactobacillus spp |
| Arm 3: Control - exclusive habitual diet | No intervention | Patients in this group will be instructed to maintain their usual diet and will be administered a placebo. After the 12-week period, if the active treatment group (Arm 1 and 2) has shown a satisfactory clinical response, we will offer specific dietary guidance and probiotics to the control group participants who did not show clinical improvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain improvement
visual analogic scale (EVA) EVA ranging from 0,0-10,0 Higher scores indicate worse pain.
Measured: 12 weeks
Secondary outcomes (4)
improvement in quality of life associated with bowel function
Gastrointestinal Quality of Live Index - GIQLI. Global score GIQLI ranging from 0-144. For the unweighted display of the global score and the dimensions, sum all item scores across the 5 domains to calculate the overall GIQLI score.
Improvement in quality of life will be assessed by the change in the Global Score. Higher scores indicate better quality of life.
Measured: 12 week
improvement of bowel function
Bristol scale. Categorizes stool consistency into seven types. Types 1 and 2 indicate constipation; types 3 and 4 are ideal stools, easy to defecate and without excess liquid; type 5 indicates a lack of fiber in the diet; and types 6 and 7 indicate diarrhea.
Measured: 12 weeks
nutritional analysis
Food record and FODMAPS analysis by Monash University
Measured: 12 weeks
analysis of intestinal microbiota
DNA extraction and genetic sequencing using the microway technique. Microbiota diversity will be assessed by alpha diversity (number of OTUs, Chao index) and beta diversity (weighted and unweighted UniFrac). Operational taxonomic units (OTUs) with a global abundance of less than 0.01% or presence in less than 25% of samples will be excluded from the analysis.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia Lenharo, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149519
- Sponsor's protocol ID
- CAAE: 84024824.1.0000.5440
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Guidance and Probiotics in the Treatment of Chronic Pelvic Pain Secondary to Endometriosis and Irritable Bowel Syndrome in Women: A Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07149519
- Acronym / sponsor ID
- CAAE: 84024824.1.0000.5440
- Conditions
- Endometriosis, Bowels Irritable
- Keywords
- dietary, probiotics, endometriosis, bowel irritable syndrome, pelvic chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 2 Sep 2025 (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.
Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities.
Detailed description
Endometriosis (EDT) is a chronic, inflammatory, hormone-dependent disease that induces cellular adhesion and proliferation, stimulates vascularization, and disrupts protective immune responses. In its intestinal form, endometriosis can lead to abdominal pain, dyschezia, and both cyclic and non-cyclic changes in bowel habits. Patients with endometriosis are 2 to 3 times more likely to develop Irritable Bowel Syndrome (IBS) than women without the condition. IBS, which is a disorder characterized by brain-gut interactions and inflammation, presents symptoms similar to those of intestinal and deep EDT, leading to diagnostic errors and delays in identifying such comorbidities. Anti-inflammatory diets have shown positive effects on symptoms in women with both conditions, supporting the theory of a similar pathophysiology. Given the already documented alteration of the gut microbiota and the female reproductive tract, and their dysbiosis associated with the development of EDT and IBS, the investigators are encouraged to further explore the connection between them. The investigators goal is to examine how dietary practices and probiotic use affect chronic pelvic pain in patients with both comorbidities. By doing so, the investigators aim to underscore the significance of exploring non-pharmacological treatments and to provide new insights for advancing the understanding and management of endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Specific dietary guidance associated with placebo. | Placebo comparator | Dietary Supplement: probiotics - Lactobacillus sppPatients in this group will receive, within 24 hours of randomization, guidance on a low-FODMAP diet, which must be followed for 12 weeks (120 days), and placebo. |
| Arm 2: Specific dietary guidance combined with probiotics. | Experimental | Dietary Supplement: probiotics - Lactobacillus sppPatients in this group will receive, within 24 hours of randomization, the same low-FODMAP diet guidance combined with probiotics (Lactobacillus and L. gasseri combinations) administered orally once daily for 12 weeks. |
| Arm 3: Control - exclusive habitual diet | No intervention | –Patients in this group will be instructed to maintain their usual diet and will be administered a placebo. After the 12-week period, if the active treatment group (Arm 1 and 2) has shown a satisfactory clinical response, we will offer specific dietary guidance and probiotics to the control group participants who did not show clinical improvement. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Women between 18 and 50 years of age who wish to participate in the clinical trial;
- Willingness to voluntarily participate in the study and accept randomization to any of the three treatment arms;
- Participating exclusively in this clinical trial during the study period;
- Signing the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP) and CONEP
Key exclusion criteria (12 listed)
- Chronic, severe, or uncompensated clinical conditions, such as: malnutrition (BMI <18); insulin-dependent diabetes (types 1 or 2); uncontrolled hypertension; lung disease such as asthma or other chronic obstructive pulmonary disease; hematologic and liver diseases; advanced-stage chronic kidney disease (grades 3, 4, and 5); metabolic disorders; and immunosuppression;
- Clinical conditions of the gastrointestinal tract that cause IBS-like symptoms, such as: inflammatory bowel disease (Chron's disease, ulcerative colitis), microscopic colitis, celiac disease, and lactose intolerance;
- Endometriosis requiring surgical treatment during the study period;
- Severe eating disorders, such as: bulimia, anorexia nervosa, and binge-eating disorder;
- Chronic use of any medication with potential interaction with probiotics, the intestinal microbiota, or the natural progression of the disease in the last 6 months (such as probiotics, antibiotics, antifungals, antihistamines, digestive medications, or treatments for constipation or diarrhea);
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 |
|---|---|---|
| probiotics - Lactobacillus sppAlso: Low FODMAPs dietaryGroup 1: Specific dietary guidance (low-FODMAP diet ) combined with placebo Group 2: Specific dietary guidance (low-FODMAP diet ) combined with probiotic Group 3: Control - Exclusive habitual diet After the 12-week period, we will evaluate the clinical improvement response of pelvic pain | Dietary supplement | Arm 1: Specific dietary guidance associated with placebo., Arm 2: Specific dietary guidance combined with probiotics. |
Primary outcome
pain improvement
Time frame: 12 weeks
visual analogic scale (EVA) EVA ranging from 0,0-10,0 Higher scores indicate worse pain.
4 secondary outcomes
improvement in quality of life associated with bowel function
Time frame: 12 week
improvement of bowel function
Time frame: 12 weeks
nutritional analysis
Time frame: 12 weeks
analysis of intestinal microbiota
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics - Lactobacillus spp in people with Endometriosis and Bowels Irritable, run by University of Sao Paulo at 1 site in Brazil.
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 12 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain improvement (time frame: 12 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 2 Sep 2025.