Clinical trial · Observational
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease
NCT04031469CI-TRIAL-00092911suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): Administrative
Summary
Brief summary (as posted)
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
Conditions
Conditions (78)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acne | — | UNRESOLVED | — |
| Alzheimer Dementia | — | UNRESOLVED | — |
| Alzheimer Dementia (AD) | — | UNRESOLVED | — |
| Alzheimer Disease | — | UNRESOLVED | — |
| Alzheimer Disease (AD) | — | UNRESOLVED | — |
| Amyotrophic Lateral Sclerosis | — | UNRESOLVED | — |
| Amyotrophic Lateral Sclerosis (ALS) | — | UNRESOLVED | — |
| Anxiety | — | UNRESOLVED | — |
| Anxiety Disorder Generalized | — | UNRESOLVED | — |
| Autism | — | UNRESOLVED | — |
| Autism Spectrum Disorder | — | UNRESOLVED | — |
| Autism Spectrum Disorder High-Functioning | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| There is no intervention in this study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- General Population
- description
- The general population will have their microbiome sequenced from stool samples provided.
- interventionNames
- Other: There is no intervention in this study
Primary outcomes (1)
- measure
- Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
- timeFrame
- One year
- description
- Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.
Secondary outcomes (1)
- measure
- Validation of Sequencing Methods
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study * 2\. Male or female patients of any age (interest is given to children to compare with mothers). Exclusion Criteria: * 1\. Refusal to sign informed consent form * 2\. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. * 3\. Postoperative stoma, ostomy, or ileoanal pouch * 4\. Participation in any experimental drug protocol within the past 12 weeks * 5\. Treatment with total parenteral nutrition * 6\. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial * 7\. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
References
Publications (1)
- DERIVEDHazan S, Stollman N, Bozkurt HS, Dave S, Papoutsis AJ, Daniels J, Barrows BD, Quigley EM, Borody TJ. Lost microbes of COVID-19: Bifidobacterium, Faecalibacterium depletion and decreased microbiome diversity associated with SARS-CoV-2 infection severity. BMJ Open Gastroenterol. 2022 Apr;9(1):e000871. doi: 10.1136/bmjgast-2022-000871. PMID 35483736