Microbiome Analysis

7

Review clinical trials related to Microbiome Analysis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
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Status: Not yet recruiting

Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings

BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Temporary diversion of intestinal transit does not reduce the risk of anastomotic failure, but it does lower the morbidity and mortality associated with potential pelvic sepsis. Unfortunately, a second surgical procedure is required to restore intestinal continuity, and this carries its own risk of complications, the most common being postoperative ileus (temporary paralysis of bowel motility associated with abdominal distension, absence of bowel movements, nausea, and vomiting), which occurs in up to 20% of cases. Several strategies have been proposed to reduce this problem, including stimulation of the efferent limb of the ileostomy (the part that is connected to the unused colon). This intervention consists of instilling a substance through the efferent limb of the ileostomy into the colon, simulating natural intestinal transit. It emerged as a harmless alternative aimed at reversing changes in the excluded colon in preparation for restoration of intestinal continuity. Several Spanish studies have investigated this technique, concluding that it is safe and significantly reduces the rate of postoperative ileus, thereby shortening hospital stay. Regarding the mechanism by which this intervention may be effective, there are studies investigating the changes that occur during diversion of intestinal transit: 1. Histopathology: reduced muscular contractility and the presence of intestinal villi in the efferent intestinal limb and excluded colon, which improve once intestinal flow is restored. 2. Microbiome: significant loss of microbiota in the defunctionalized colon, which progressively recovers with natural intestinal transit and reintroduction of a fiber-rich diet. Structural and microbiota-related changes favor the development of diversion colitis, a condition associated with erratic bowel habits once intestinal transit is restored. In an attempt to reverse this condition, several products have been tested for stimulation of the efferent limb of the ileostomy: probiotics, short chain fatty acids, saline solution with a thickening agent, and the patient's own intestinal contents, a well-tolerated and effective technique, in some cases superior to saline-based alternatives. Overall, the available evidence is of low quality due to the limited number of patients studied and protocol variability. For this reason, we propose the implementation of a protocol for stimulation of the distal ileostomy limb prior to ileostomy closure, either with saline solution and thickening agent (the most widely described technique in the literature) or physiological stimulation using the patient's own intestinal contents. The protocol consists of several sessions in which the instilled volume is progressively increased. This intervention will be performed on an outpatient basis, once daily, during the two weeks prior to surgery. This process promotes the onset of bowel movements through the anus, which progressively become more formed and less frequent, approaching a more normal bowel habit. Only minor adverse effects have been described with this technique, including cramp-like abdominal pain in 27.6% of sessions. Recently, a nationwide study confirmed the favorable clinical outcomes following distal ileostomy limb stimulation before ileostomy closure. However, to our knowledge, no studies have evaluated its effect on intestinal microbiota. HYPOTHESIS Distal limb stimulation of the ileostomy before its closure helps in the recovery of the colorectal microbiome and tissue. This associates with lower postoperative complications, specially postoperative ileus. OBJECTIVES To gain knowledge regarding changes in intestinal microbiota composition before and after stimulation, in order to better understand recovery of intestinal function following this procedure. We will also analyze outcomes after ileostomy closure following efferent limb stimulation, determining the incidence of postoperative complications, particularly postoperative ileus. METHODOLOGY Patients will be randomly assigned to one of three groups: 1. Control (no intervention other than the usual preoperative protocol) 2. Stimulation with serum and thickener 3. Stimulation with own stoma output Samples will be collected in all patients: 1. Stoma output 2. Stool, before stimulation, if performed 3. Stool, after stimulation, if performed 4. Stool, a month after surgery For a group of patients, the ones recruited at Hospital Clínic, rectal biopsies will also be collected before and after stimulation, to compare the effect of the treatment in the colonic tissue. We will collect clinical data during the whole process regarding postoperative complications.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital Clinic of BarcelonaUpdated: Jun 17, 2026
Eligibility criteria

Patients 18 yo and older, with a loop ileostomy after colorectal surgery for mal... [+2]

Patients with a terminal ileostomy or a closed distal limb, inaccesible to preop... [+2]

Status: Recruiting

Influence of the Gut Microbiome on Blueberry Polyphenol Metabolites

The objective of this study is to determine whether inter-individual differences in the gut microbiome influence exposure to blueberry polyphenol metabolites. We will use pharmacokinetics of blueberry polyphenols after an acute blueberry exposure to group individuals into "metabotypes", groups of individuals based on similarity in their metabolite profiles. We will then use multi-omic approaches to determine whether the gut microbiome predicts an individual's metabotype.

Participants needed: 125
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Colorado State UniversityUpdated: May 26, 2026Locations: 1
Eligibility criteria

Healthy adults ≥18 years of age [+2]

Age <18 years [+11]

Status: Not yet recruiting

Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers. This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: OneCarbonUpdated: Mar 9, 2026
Eligibility criteria

Aged 18 years or older at the time of providing informed consent. [+7]

β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosid... [+8]

Status: Recruiting

Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption

The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are: * Does a ketone ester reduce age-related signatures in the gut microbiome? * What changes occur in the gut microbiome after consuming a ketone ester? Participants will: * Take a ketone ester every day for seven (7) days * Collect and ship stool samples within seven (7) days before, during, and within seven (7) days after the study period * Measure their ketone levels with a urine strip every day after having the drink * Answer questions about their typical diet on a normal day * Record their symptoms, if any arise

Participants needed: 20
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Jan 26, 2026Locations: 1
Eligibility criteria

Subject is male or female, 18 to 40 years of age, inclusive, at Virtual Visit 1. [+5]

Subject is unable to converse in English or Spanish [+12]

Status: Recruiting

Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)

Cancer of the stomach and oesophagus is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. The study team has developed a non-invasive test for cancers of the stomach and oesophagus based on the detection of volatile organic compounds in exhaled breath. These compounds are known to be produced by both cancers as well as cancer associated bacteria within the gut. The proposed innovation is to improve the accuracy of this test by investigating whether simple metabolic substrates can increase the production of these volatile organic compounds by both the tumour and its associated bacteria.

Participants needed: 648
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: Imperial College LondonUpdated: Jan 31, 2025Locations: 1
Eligibility criteria

Aged 18-90years [+2]

Oesophageal squamous cell carcinoma [+23]

Status: Not yet recruiting

A Randomized, Double-Blind Study to Assess the Effect of a Postbiotic on Oxidative Stress and Exercise Performance

This is a prospective, randomized, placebo controlled, double-blind study to assess the effects of a postbiotic blend on exercise induced oxidative stress markers and exercise performance in healthy adult.

Participants needed: 80
Trial details
Age: 18-45Biological sex: AllType: InterventionalSponsor: Lindenwood UniversityUpdated: Jan 28, 2025Locations: 1
Eligibility criteria

Male or female participants between 18 - 45 years of age [+5]

Body mass index <18.5 to <29.9 kg/m2 (Inclusive) [+14]

Status: Not yet recruiting

Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery

This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.

Participants needed: 60
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Acibadem Maslak HospitalUpdated: Jan 24, 2025Locations: 6
Eligibility criteria

Adults aged between 18 and 65 years [+1]

History of infection or antibiotic use within the last 12 weeks. [+5]