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Not yet recruitingNCT07922408Endo-SIBOUpdated Nov 6, 2026

Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis

An interventional study of Gastroduodenoscopy, luminal aspirate, mucosal biopsies, collection of mucus, lactulose breath test in SIBO and Endometriosis, sponsored by Insel Gruppe AG, University Hospital Bern. Not yet recruiting at 1 site in Switzerland. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Diagnostic

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

This is a prospective, single-arm observational diagnostic study without therapeutic intervention or control arm. Participants undergo diagnostic assessment for SIBO including lactulose hydrogen/methane breath testing and gastroduodenoscopy with collection of small intestinal luminal aspirate, mucus and mucosal biopsies, as well as stool, saliva and venous blood sampling. Gastroduodenoscopy is performed only when clinically indicated and is not performed solely for study purposes. During the clinically indicated endoscopic procedure, two additional mucosal biopsies are obtained for study-specific analyses.

Read the detailed description

Endometriosis is a common inflammatory disease affecting approximately 10% of all premenopausal women. It is characterized by the presence of ectopic endometrial tissue at extrauterine sites. Endometriosis causes severe pain episodes and may lead to infertility.

There are different types of endometriosis, including superficial peritoneal endometriosis, ovarian endometriosis, and deep infiltrating endometriosis (DIE). Superficial peritoneal endometriosis refers to lesions located on the peritoneal surface and is considered the most common subtype. Ovarian endometriosis is associated with cystic lesions within the ovaries, commonly referred to as endometriomas. Deep infiltrating endometriosis (DIE) describes lesions penetrating more than 5 mm beneath the peritoneal surface and often affecting surrounding structures and organs.

Endometriosis not only causes severe cyclical and chronic pain but also affects quality of life across nearly all dimensions of daily living. Many affected individuals additionally suffer from fatigue, infertility, psychological distress, and pronounced gastrointestinal symptoms. These are often nonspecific and may include digestive complaints, abdominal cramping to severe abdominal pain, bloating, and alternating diarrhea and constipation. The underlying cause of these symptoms often remains unclear, which means they are frequently inadequately treated or not treated at all.

These factors highlight the urgent need for a better understanding of the disease mechanisms-particularly the frequently observed gastrointestinal manifestations.

SIBO (Small Intestinal Bacterial Overgrowth) is a condition characterized by gut dysbiosis, with an increased number and/or presence of colonic bacteria in the small intestine. Typical symptoms include bloating, diarrhea and gas formation, which may overlap with other gastrointestinal diseases. The intestinal micro¬biome compromises a dynamic, highly complex ecosystem with a very high diversity. The bacterial density varies greatly along the gastrointestinal tract. While the colon can contain up to 1012 bacteria per gram of stool, the proxi¬mal small intestine near the stomach is almost sterile. The sterility is due to antimicrobial mechanisms such as gastric acid, pancreatic enzymes, bile and defensins. The microbiome has proven role in numerous diseases, including inflammatory bowel diseases as well as Crohn's disease and Ulcerative Colitis, metabolic diseases and neuropsychiatric disorders. The above mentioned sterility is disturbed in patients with SIBO. Typical symptoms of SIBO include bloating, diarrhea and gas formation, which may overlap with other gastrointestinal diseases. To the best of the authors knowledge, only one case-control study has investigated the correlation between these two conditions (Philippe Halfon et al., International Journal of Gynecology and Obstetrics, 2025). This study found that 91.9% of women with endometriosis who reported digestive symptoms tested positive in a lactulose breath test (BT) for SIBO, Intestinal Methanogen Overgrowth (IMO), or both. Although research directly linking endometriosis and SIBO is scarce, there are studies exploring associations between other dysbiotic diseases and endometriosis. A Danish cohort study, for example, reported a 50% increase in the risk of IBD in women with endometriosis compared to controls (Francesca Chiaffarino et al., European Journal of Obstetrics and Gynecology and Reproductive Biology, 2020). Furthermore, a meta-analysis reported that approximately half of the patients diagnosed with SIBO through a lactulose breath test, and about one fifth of those diagnosed using a glucose breath test were also diagnosed with IBD (Noemi Salmeri et al., Microorganisms, 2023). These findings highlight the importance of further investigating a potential correlation between SIBO and endometriosis, particularly since the majority of women with endometriosis report significant gastrointestinal symp¬toms that overlap with those described by SIBO patients.

The gold standard of reliable diagnostic methods for both, endometriosis and SIBO remain invasive. Regarding SIBO, non-invasive tests as the lactulose breath test are now being used but have not yet replaced the invasive diagnostic methods. Concerning Endometriosis, a paradigm shift has taken place in the diagnostic approach in recent years. This development has been driven by improved non-invasive diagnostic accuracy, particularly through expert transvaginal ultrasound, as well as by the high clinical suggestiveness of a carefully taken medical history. In addition, the invasive nature of surgery-especially in young women-has contributed to a more conserva-tive diagnostic strategy. According to current guidelines, empirical treatment may already be initiated on the basis of a clinical suspicion of endometriosis, and diagnostic laparoscopy is no longer recommended solely for the purpose of establishing the diagnosis. However, for research purposes and for a definitive confirmation of the diagnosis, histological verification obtained during surgery remains the gold standard.

A novel non-invasive testing of endometriosis has recently been proposed to be performed with a reliable saliva test (Ziwig Endotest®). A saliva sample is used to extract salivary microRNA (miRNA) to identify phenotypic profiles characteristic of endometriosis, identified by NGS and modeled by AI. MiRNAs are small, non coding RNA molecules involved in the regulation of gene expression and are known to reflect disease-specific molecular patterns. In patients with endometriosis, specific miRNAs have been identi-fied that allow to differentiate between affected and non-affected individuals.

The diagnostic performance of salivary microRNA profiling for endometriosis has been investigated in several consecutive studies. An initial prospective proof-of-concept study first demonstrated the potential of a saliva-based microRNA signature to discriminate between patients with and without endo-metriosis, reporting a sensitivity of 96.7% and a specificity of 100% (Bendi-fallah et al., J Clin Med, 2022). This was followed by a prospective external validation study, in which the test showed a sensitivity of 96.2% and a speci-ficity of 95.1% (Bendifallah et al., NEJM Evidence, 2024). More recently, find-ings from a large prospective multicenter cohort study further supported these results, with a reported sensitivity of 97.3% and specificity of 94.1% (Bendi¬fallah et al., NEJM Evidence, 2025).

In the proposed study, we aim to analyze the prevalence of SIBO in patients with a confirmed diagnosis of endometriosis-either histologically verified or identified through a positive Ziwig Endotest®. SIBO testing will be conducted at the clinic for gastroenterology, Bern using standardized diagnostic proce-dures, including the lactulose breath test, gastroduodenoscopy with collection of luminal aspirate, mucus and mucosal biopsies, and complementary stool analyses. The diagnostic gold standard for SIBO is the microbiological analysis of small intestinal luminal aspirate. SIBO is considered confirmed when bacterial concentrations exceeding 103. As an additional non-invasive diagnostic method, a hydrogen (H2) breath test using lactulose may be performed. Although this method has a relatively limited diagnostic accuracy (reported sensitivity around 42%, specificity around 71%), it represents a useful complementary tool for the detection of SIBO, particularly due to its non-invasive nature (Losurdo et al., Journal of Neurogastroenterology and Motility. 2020.) Prior to the test, the patient must fast for at least 12 hours. After a baseline breath sample will be collected, the patient will drink a lactu¬lose solution. Then, breath samples will be collected at regular intervals and analyzed for hydrogen and methane concentrations, which indicate bacterial fermentation occurring in the small intestine. Diagnostic criteria used to indicate SIBO by Lactulose-breath test is an increase in hydrogen (H2) of > 20 ppm above baseline within 90 minutes after ingestion (or methan levels > 10 ppm at any time during the test).

The objective of the study is to assess the prevalence of SIBO within this patient population and to systematically explore potential associations between the two conditions.

02

Conditions studied

  • SIBO
  • Endometriosis

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Keywords

  • Endometriosis
  • SIBO
  • prevalence of SIBO in endometriosis
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In context

Endometriosis

920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.

This study's planned enrollment of 50 is below the median of 67 across 540 interventional studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • as documented by signature
  • Age 18 or older
  • Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
  • Diagnosis of endometriosis (Ziwig Endotest® or confirmed)

Exclusion criteria

Exclusion Criteria:

  • Pregnant (positive β-HCG in the blood) or breastfeeding women Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia)
  • Presence of medical conditions contraindicating a saliva test
  • Diagnosis of another gastrointestinal major diagnosis
  • Presence of any condition known to associate with/ increase risk for SIBO (other than endometriosis) namely

    1. Scleroderma, diabetic neuropathy, amyloidosis, post-vagotomy, morbid obesity , non-alcoholic fatty liver disease, liver cirrhosis, cystic fibrosis, irritable bowel syndrome, altered intestinal anatomy such as diverticula.
    2. Patients with intake of medicaments known to inhibit motility or gastric acid secretion
    3. Patients with choledocholithiasis or within the biliary tree or at the ampullary region obstructing biliary outflow
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    50 patients with endometriosis

    patients with endometriosis, histologically confirmed or confirmed by a positive Ziwig Endotest, will undergo testing for SIBO (small intestinal bacterial overgrowth) by hydrogen breath test as well as gastroduodenoscopy with samples taken

    Diagnostic Test: Gastroduodenoscopy, luminal aspirate, mucosal biopsies, collection of mucus, lactulose breath test

Interventions

  • Diagnostic testGastroduodenoscopy, luminal aspirate, mucosal biopsies, collection of mucus, lactulose breath test

    SIBO testing will be conducted at the clinic for gastroenterology, Bern using standardized diagnostic procedures, including the lactulose breath test, gastroduodenoscopy with collection of luminal aspirate, mucus and mucosal biopsies, and complementary stool analyses. The diagnostic gold standard for SIBO is the microbiological analysis of small intestinal luminal aspirate. SIBO is considered confirmed when bacterial concentrations exceeding 103. As an additional non-invasive diagnostic method, a hydrogen (H2) breath test using lactulose may be performed.

    Also known as: Gastroduodenoscopy, Breath Test, Gastroscopy, luminal aspirate, lactulose breath test, mucus, mucosal biopsies

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What researchers measure

Primary outcomes

  1. prevalence of SIBO in premenopausal women with endometriosis

    Proportion of participants diagnosed with SIBO according to the diagnostic criteria specified in the study protocol

    Time frame: At baseline, during the diagnostic study assessment

Secondary outcomes

  1. Diagnostic accuracy of breath testing

    investigating diagnostic accuracy of breath testing considering small intestinal aspirate cultures as goldstandard in the diagnosis of SIBO in this cohort.

    Time frame: At baseline, during the diagnostic study assessment

  2. Investigation of the associations between endometriosis subtypes, gastrointestinal symptoms, and presence of SIBO.

    Investigation if there are associations between endometriosis subtypes, gastrointestinal symptoms, and presence of SIBO.

    Time frame: At baseline, during the diagnostic study assessment

  3. Analysis of the microbial composition of the small intestine in patients with endometriosis with and without SIBO.

    Analysis of the microbial composition of the small intestine in patients with endometriosis with and without SIBO, comparision of differences

    Time frame: At baseline, during the diagnostic study assessment

07

Study locations

1 site
  • University Clinic of Obstetrics and Gynecology, Inselspital Bern
    Bern, 3010, Switzerland
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References and documents

Publications

  • Chiaffarino F, Cipriani S, Ricci E, Roncella E, Mauri PA, Parazzini F, Vercellini P. Endometriosis and inflammatory bowel disease: A systematic review of the literature. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:246-251. doi: 10.1016/j.ejogrb.2020.06.051. Epub 2020 Jun 26. PubMed 32629225 ↗
  • Halfon P, Estrade JP, Penaranda G, Choucroun N, Bouaziz J, Nicolas-Boluda A, Retornaz F, Gurriet B, Plauzolles A. High prevalence of small intestinal bacterial overgrowth and intestinal methanogen overgrowth in endometriosis patients: A case-control study. Int J Gynaecol Obstet. 2025 Jul;170(1):284-291. doi: 10.1002/ijgo.70005. Epub 2025 Feb 17. PubMed 39959963 ↗

Individual participant data

Plan to share: No — Participant data will be collected and stored in coded form. Personal identi-fiers are kept separately and accessible only to authorized staff. All data are stored on a secure server (REDCap, handled by CTU Bern (clinical trial unit)) according to Swiss data protection law. Only non-identifiable data will be used for analysis and publication.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Jan 2030, 35 months later.

Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 35 months is above that.

Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Feb 2027
Primary completionEst.
Jan 2030
CompletionEst.
Dec 2030
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922408
Collaborators
Stiftung Marie-Lou-Ringgenberg
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Feb 2027 (estimated)
Primary completion
Jan 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Cloé Vaineau, Dr. med.
Contact
cloe.vaineau@insel.ch
0041797165065
Andrea Gmuer, Dr. med.
Contact
andrea.gmuer@insel.ch
0041316321010

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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