An observational study in Irritable Bowel Syndrome, sponsored by Zhongshan Hospital Xiamen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Zhongshan Hospital Xiamen University · Observational
Irritable Bowel Syndrome (IBS) is a common functional bowel disorder with complex and not yet fully elucidated pathophysiological mechanisms. Recent research suggests that gut microbiota dysbiosis, particularly small intestinal bacterial overgrowth (SIBO), may play a key role in the generation of IBS symptoms. However, the vast majority of current studies have focused on fecal samples, which primarily reflect the colonic microbiota. The small intestinal microbiota, which is directly involved in nutrient digestion and absorption and more prone to dysbiosis, remains understudied due to the challenges in obtaining samples.
This study aims to utilize intestinal sampling capsules to directly collect small intestinal fluid samples from both IBS patients and healthy controls. The community structure, diversity, and compositional differences of the small intestinal microbiota will be analyzed using 16S rRNA gene sequencing and metagenomic sequencing technologies, while the metabolic profiles of the small intestinal fluid will be detected via untargeted metabolomics.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 90 is below the median of 160 across 191 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Zhongshan Hospital Xiamen University is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The cohort included Rome IV-diagnosed IBS patients without confounding surgical or medication history, along with age- and sex-matched healthy controls.
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.
Experimental Group： Aged 18-65 years, male or female. Meets the Rome IV diagnostic criteria for IBS The absence of organic gastrointestinal disease that could explain the symptoms.
Provides and voluntarily signs the informed consent form. Control Group： Age and sex-matched to the IBS patient group. No history of chronic digestive diseases or current gastrointestinal symptoms. Has not used antibiotics, proton pump inhibitors, probiotics, or other medications known to affect gut microbiota within the past month.
Provides informed consent and voluntarily signs the informed consent form.
Exclusion Criteria:
History of gastrointestinal surgery (excluding appendectomy). Presence of concomitant organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, gastrointestinal tumors).
Presence of severe concomitant cardiac, hepatic, renal, endocrine, hematologic, or neurological diseases.
Long-term use of medications known to affect gastrointestinal motility (e.g., opioids).
Pregnancy, lactation, or women planning a pregnancy. Conditions contraindicating the use of capsule endoscopy, such as dysphagia, or known gastrointestinal strictures, diverticula, or obstruction.
Any other condition deemed by the investigator as unsuitable for participation in the study.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants ingest an intestinal sampling capsule for small intestinal fluid collection. Upon capsule retrieval, the samples are analyzed for their microbial DNA and metabolite content.
All participants ingest an intestinal sampling capsule for small intestinal fluid collection. Upon capsule retrieval, the samples are analyzed for their microbial DNA and metabolite content.
Identify the specific differences in the core architecture of the small intestinal microbiota between IBS patients and healthy individuals.
Intestinal content samples from different regions were collected from IBS patients and healthy subjects using smart enteric-coated sampling capsules. These samples subsequently underwent 16S rRNA gene sequencing and metagenomic sequencing to analyze microbial composition, alongside untargeted metabolomics to detect metabolic differences. The regional variations in both the microbiome and metabolome were then analyzed in the IBS cohort.
Time frame: 6 Months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2025; primary completion for Oct 2028, 36 months later.
Of 51 non-industry observational studies under Irritable Bowel Syndrome, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 193. This study's planned 36 months is below that.
Counting every sponsor, half of 65 studies reached it within 40 months; a quarter within 21 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhongshan Hospital Xiamen University