Clinical trial · Interventional
Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
NCT06831539CI-TRIAL-00086230PEGrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Healthy Participants | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEGLyte bowel preparation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Healthy volunteer participant cohort
- description
- For healthy volunteer participants, PEG bowel preparation will be administered and participants will collect stool samples before and after PEG at specified timepoints.
- interventionNames
- Drug: PEGLyte bowel preparation
Primary outcomes (1)
- measure
- To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation.
- timeFrame
- At week 1
- description
- Study of the gut microbiota composition at 1 week after bowel preparation.
Secondary outcomes (1)
- measure
- Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy volunteer participant cohort: 1. \> 18 years of age 2. The participant has provided documented informed consent for the participation and to complete PEG bowel preparation and return collected stool samples. Exclusion Criteria: * An ileus * Significant gastric retention * Suspected or established mechanical bowel obstruction * Inflammatory or infectious gastrointestinal condition * Neurologic or cognitive impairment that prevents safe swallowing * Recent history (\<1 year) of cancer that still requires ongoing treatment * Recent use of antibiotics 1 month prior to participation in the trial * History of cardiac disease * History of active renal dysfunction * Presence of any absolute contraindication to PEG bowel preparation according to manufacturer labeling
References
Publications (0)
Data not yet available
No reference posted for this study.