Microbial Colonization Clinical Trial
— RestoreGutOfficial title:
"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)" - A Double-blinded Randomized Controlled Feasibility Trial
This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. We will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Gestational age < week 38+0 days - Proficient in spoken/written Danish - Single pregnancy (no twins or triplets) - Pre-pregnancy BMI between 18.5 and 35 kg/m2 - No chronic intestinal, endocrine, cardiac, or kidney disorders - No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism) - No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results. - Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed). Exclusion Criteria: Maternal: - Use of antibiotics within one month of stool donation - Acute gastroenteritis within one month of stool donation - Use of antibiotics within one month of birth - Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations ("Regler for tappepauser" - blooddonor.dk) - Positive test results for pathogens during donor material screening. - Antibiotic treatment at birth (vaginal births only) - Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section. Infant: - Instances of major birth defects or intrauterine growth retardation (IUGR) - Infants requiring pediatric support at the time of transplant administration |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Copsac, DBAC | Gentofte | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Professor Klaus Bønnelykke |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbial development trajectory | Compositional differences to placebo-treated infants | During the first year of life | |
Secondary | Microbial development trajectory | Compositional resemblance to vaginally-born infants | During the first year of life |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05414994 -
Assessment of the Ocular Microbiome in Health and Disease
|
||
Completed |
NCT04769882 -
Er:YAG Laser Effects on Microbial Population in Conservative Dentistry
|
N/A | |
Completed |
NCT04766528 -
Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
|
N/A | |
Completed |
NCT03720314 -
Microbiota Profiling in IBS
|
||
Completed |
NCT04122612 -
Shaping Microbiome in the First 1,000 Days of Life
|
||
Not yet recruiting |
NCT05405634 -
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
|
||
Not yet recruiting |
NCT04895774 -
Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
|
||
Recruiting |
NCT05992688 -
The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
|
N/A | |
Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
Completed |
NCT05175833 -
Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19
|
Phase 2 | |
Recruiting |
NCT04836910 -
Microbiome and Polycystic Ovaries
|
||
Recruiting |
NCT05603650 -
Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
|
N/A | |
Completed |
NCT04991818 -
MSC - OneBiome UX Pilot Study
|
N/A | |
Completed |
NCT05575050 -
Impact of Teeth Brushing in Ventilated COVID-19 Patients.
|
N/A | |
Completed |
NCT04374955 -
The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content
|
N/A | |
Recruiting |
NCT04140747 -
Transfer of Strictly Anaerobe Microbes From Mother to Child
|
||
Recruiting |
NCT04111471 -
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
|
N/A | |
Suspended |
NCT03220282 -
The Milk, Growth and Microbiota Study
|
N/A | |
Completed |
NCT03422562 -
Probiotics and Intestinal Microbiome in Preterm Infants
|
Phase 3 | |
Recruiting |
NCT05695196 -
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
|
Phase 1 |