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Dietary Supplement

Product Tolerability Arm for Chronic Constipation

Q: Is the trial open to individuals below a certain age threshold?

<p>This medical experiment is inviting volunteers between the age of majority and 75 years old to participate.</p>

Q: Does this clinical trial have open enrolment at present?

<p>Affirmative. Clinicaltrials.gov data reveals that this clinical investigation, first listed on September 23rd 2021, is currently seeking participants. Approximately 200 patients are required to be sourced from 1 healthcare facility.</p>

N/A

Waitlist Available

Led By Peter Swann, MD

Research Sponsored by Microbiome Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial is to see if a new medication is tolerated by those with a bowel movement disorder. It will assess how well the subjects tolerate the medication by monitoring their bowel movements, questionnaires, and any adverse effects.

Eligible Conditions

Chronic Idiopathic Constipation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tolerability as assessed using a PRO questionnaire, a 4 question Daily BM Questionnaire

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Product Tolerability ArmActive Control1 Intervention

active product: MHS 1031 Panosyl-isomaltooligosaccharides liquid 1 g (1.4 ml) per day

Group II: Placebo Tolerability ArmPlacebo Group1 Intervention

Placebo liquid 1 g (1.4 ml) per day

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Microbiome Health SciencesLead Sponsor

2 Previous Clinical Trials

367 Total Patients Enrolled

Peter Swann, MDPrincipal InvestigatorMicrobiome Health Sciences

2 Previous Clinical Trials

367 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved with this clinical trial?

"Affirmative. Clinicaltrials.gov records suggest that this clinical trial, which was initially posted on September 23rd 2021, is presently accepting participants. Approximately 200 patients are being sought out from 1 particular medical centre."

Answered by AI

Do I meet the requirements to participate in this medical study?

"This scientific research is seeking 200 subjects with dyschezia aged between 18 and 75 to participate. Participants need to be able to meet the following prerequisites: electronic Daily Bowel Movement and Symptoms Questionnaire completion, daily medication reconciliation surveys (Screening, Product Phase, and Product/Placebo Phase), bi-weekly PAC-SYM &PAC QOL questionnaire compilation, monthly Study Participant Global Assessment questionnaires for a 2 week Screening Period plus 8 weeks in the randomized Product/Placebo Stage, 4 weeks in an open label Product stage followed by another 2 week Follow up stage; BMI ≥ 19 & < 35 kg/m2"

Answered by AI

Is the trial open to individuals below a certain age threshold?

"This medical experiment is inviting volunteers between the age of majority and 75 years old to participate."

Answered by AI

Does this clinical trial have open enrolment at present?

"Affirmative. Clinicaltrials.gov data reveals that this clinical investigation, first listed on September 23rd 2021, is currently seeking participants. Approximately 200 patients are required to be sourced from 1 healthcare facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)

2021. "Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05129618.