Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
K
Kate Hawa
Primary Investigator
Enrolling By Invitation
2-21 years
All
Phase
4
50 participants needed
2 Locations
Brief description of study
This study will evaluate changes in the fecal microbiome in constipated pediatric patients
before and after antegrade continence enema placement and initiation of antegrade enemaushes. Subjects will have their microbiome sequenced prior to placement by obtaining a. Pre-antegrade continence enema placement results will be compared to fecalbtained at 0, 4, 8 months after placement of the antegrade continence enema andgolytely flushes to look for changes in bacterial diversity.
Detailed description of study
This is a prospective, longitudinal study of children 2 -18 years of age who undergo aAntegrade Continence Enema (MACE) appendicostomy or cecostomy for treatmenthronic functional constipation as defined by the Rome IV criteria. Only patients withy on colonic manometry (CMS) will be included. The antegrade enema flushdication regimen will be randomized in 1:1 ratio of PEG 3350 and PEG3350 with electrolytes.
The study statistician will create a blocked randomization schedule which will be uploadedREDCap. Glycerin and stimulant laxatives will be titrated as needed by a pediatric
gastroenterologist in conjunction with the pediatric general surgery team. Neither patientviders will be blinded to laxative randomization as objective data in the form ofbiome composition is being evaluated.
Patients will have a pre-MACE placement stool sample obtained at time of colonic motilityudies and repeat stool samples collected at 1 month, 4 months and 8 months post-MACEd initiation of antegrade enemas. Post-MACE samples will be submitted at standardw-up appointments. All stool samples will be self-collected by patients. Samples will bed with the OMNIgene GUT kit which provides stabilization of DNA at room temperatureup to 60 days. Once the sample is collected by the research team, sample tubes will bed at -80 Celsius until all samples are collected and sent for sequencing. Pre-MACE stoolwill be collected while abstaining from osmotic laxative therapy for one week. Ifdo not spontaneously pass stool during the week of osmotic laxative abstention,will be collected from the first bowel movement after pre-CMS bowel flush with PEG 3350
with or without electrolytes has been initiated. Data regarding if stool collection occurred
before or after receiving PEG 3350 with or without electrolytes for CMS bowel flush will beded. Patients will perform daily flushes after MACE placement and post-MACE stoolwill be collected within the first 10 minutes of flush initiation.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Constipation, Riley
-
Age: Between 2 Years - 21 Years
-
Gender: All
Inclusion Criteria:
- Recalcitrant chronic functional constipation necessitating a MACE appendicostomy ory for treatment at Riley Hospital for Children
- Intact colonic motility as evidenced by CMS studies
Exclusion Criteria
- Underlying anatomic or pathologic etiology for constipation
- History of prior gastrointestinal surgery
- Underlying severe GI disease unrelated to the patient's chronic constipation
- Use within the past month of probiotic supplements, prebiotic supplements orbiotics
Updated on
13 Sep 2024.
Study ID: 17083, PGI-IIR-MACE-STUDY
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