Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03918330
• Other study ID #: SpIM
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Research on the human intestinal microbiota is common as there is rising evidence of its influence on host physiology and several diseases. Predominantly, it has been based on analyses of faecal samples because of their easy sampling. A minority of studies investigated the gut microbiota using mucosal samples. Not much is known about the spatial differences in microbiota composition along the large bowel. The spatial differences of the gut microbiota without preparation of the bowel have not been analysed yet. Furthermore, the composition of the microbiota of the luminal gut content has not been analysed yet.

This study aims to gain knowledge of the microbial composition of luminal and mucosal samples at different segments of the lower gastrointestinal tract: ileum, caecum, ascending colon, transverse colon, descending colon, sigmoid colon and rectum, as well as of rectal swabs and faecal samples.

Description:

The investigators aim to evaluate complete colonoscopies from 10 healthy subjects. This study is used as a first explorative study of how the human gut microbiota is distributed along the lower gastrointestinal tract. No comparable studies in an uncleansed bowel have been performed so far. The number of subjects is based on other studies investigating the microbial composition of mucosal- and faecal-associated microbiota in which a sample size of 10 was enough to detect a difference. An equal number of men and women will be recruited. Drop-outs will be replaced.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent

2. Age: 18-65 years

Exclusion Criteria:

1. Known organic gastrointestinal disease (e.g. inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea or constipation)

2. History of or present gastrointestinal malignancy or polyposis

3. Recent (gastrointestinal) infection (within last 6 months)

4. History of major gastrointestinal surgery (e.g. gastric bypass)

5. Eosinophilic disorders of the gastrointestinal tract

6. Current communicable disease (e.g. upper respiratory tract infection)

7. Malignant disease and/or patients who are receiving systemic anti-neoplastic agents

8. Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation

9. Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)

10. Autoimmune disease and/or patients receiving immunosuppressive medications

11. Major relevant allergies (e.g. food allergy, multiple allergies)

12. Chronic pain syndromes (e.g. fibromyalgia)

13. Chronic fatigue syndrome

14. Obesity (body mass index>30) or metabolic syndrome

15. Antimicrobial treatment or prophylaxis within the last 3 months

16. Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors

17. Females who are pregnant or breast-feeding

18. Known clinically significant abnormal laboratory values

19. Abuse of alcohol or drugs

20. Probiotic intake within the last 6 weeks

21. Bowel cleansing within the last 6 months

22. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
Sweden	Örebro university	Örebro	Örebro County

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the composition of the microbiota in luminal and mucosal samples along the large intestine Composition of the microbiota in luminal as well as mucosal samples	16S rRNA-based next generation sequencing	1 day
Secondary	Microbial composition of rectal and faecal microbiota	16S rRNA-based next generation sequencing	1 day
Secondary	Metabolic profile in faecal samples along the intestinal tract	metabolomics	1 day
Secondary	Gene expression of transporters for bacterial products in mucosal biopsies along the colon		1 day