Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment

Healthy Clinical Trial

Official title:

Changes in Microbiota and Biochemical Markers in Healthy Subjects Before and After Meditation Practices in a Controlled Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06306469
• Other study ID #: PHRI-2022-1001
• Status: Completed
• Phase: N/A
• Start date: July 2, 2022
• Est. completion date: January 11, 2024

Study information

• Verified date: March 2024
• Source: Pranic Healing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.

This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being.

Description:

The present study was designed as a single-arm pilot scale to understand the temporal changes in both gut and oral microbiome of the practitioners at a meditation-cum-spiritual retreat in a controlled environment. There was open communication between all the participants before, during and after the retreat. As all the practitioners followed group practices in one location under the supervision of the senior instructors, separate assessment of the adherence of the practitioners to the protocol was not performed. Oral and fecal samples of practitioners were collected at the start (Day0: T1), middle (Day3-5: T2) and end (Day7-9:T3) of the retreat in a sterile containers. Amplicon sequencing was performed from extracted DNA to study changes in microbiome profile during retreat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 11, 2024
• Est. primary completion date: July 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• must provide written informed consent prior to initiation of any study procedures

• was able to understand and agreed to comply with planned study procedures (agreed to the collection of specimens (saliva and fecal) before, during and after the study

• male or non-pregnant female greater than 18 years of age at time of enrolment

• must have a distinct Arhatic level (0-5 level) and performed meditation and MTH practices from once a week to more than 3 times a week prior to this retreat

Exclusion Criteria:

• concomitant disease that requires any medical treatment

• pregnancy

• any antibiotic treatment in the past two weeks

• pediatric population

• clinical apparent infectious disease

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Meditation practice
physical and breathing exercises

Locations

Country	Name	City	State
United States	Pranic Healing Research Institute	Lyndhurst	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pranic Healing Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hammerschlag R, Sprengel ML, Baldwin AL. Biofield therapies: Guidelines for reporting clinical trials. Complement Ther Med. 2023 Dec 28:103011. doi: 10.1016/j.ctim.2023.103011. Online ahead of print. — View Citation

Househam AM, Peterson CT, Mills PJ, Chopra D. The Effects of Stress and Meditation on the Immune System, Human Microbiota, and Epigenetics. Adv Mind Body Med. 2017 Fall;31(4):10-25. — View Citation

Raman M, Vishnubhotla R, Ramay HR, Goncalves MCB, Shin AS, Pawale D, Subramaniam B, Sadhasivam S. Isha yoga practices, vegan diet, and participation in Samyama meditation retreat: impact on the gut microbiome & metabolome - a non-randomized trial. BMC Complement Med Ther. 2023 Apr 5;23(1):107. doi: 10.1186/s12906-023-03935-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the changes in gut and oral microbiome profile of the participants during retreat	Stool and oral samples were collected from the participants for three timepoints (T1: 1 day, T2: 3-5 days, and T3: 7-9 days) and changes in gut microbiome and oral microbiome were assessed through 16S rRNA gene amplicon sequencing. T1 was considered as baseline data.	Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days