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

NCT05129618 | Completed

• 1 other identifier: MHS-1031-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase) to Week 8 (Day 56). The primary analysis will be conducted to assess the tolerability of MHS 1031 product and of the formulated placebo in randomized subjects with CIC diagnosed according to a modified Rome IV criteria.

Conditions

Constipation Chronic Idiopathic

Keywords

CIC; microbiome; PIMO; Panosyl-isomaltooligosaccharides; prebiotic

Outcome Measures

Primary Outcomes (1)

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

  A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. Tolerability is defined as no overall worsening of constipation measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores. More complete spontaneous bowel movements is better, fewer is worse.

  8 weeks

Study Arms (2)

Product Tolerability Arm

ACTIVE COMPARATOR

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

Dietary Supplement: MHS 1031

Placebo Tolerability Arm

PLACEBO COMPARATOR

Placebo liquid 1 g (1.4 ml) per day

Other: placebo

Interventions

MHS 1031 DIETARY_SUPPLEMENT

prebiotic syrup in individual sachets containing 1g (1.4 ml) of panosyl-isomaltooligosaccharides

Product Tolerability Arm

placebo OTHER

liquid combination formulation of Neotame 7.92 mcg/g, phosphoric acid, and sterile water, designed to have the same degree of sweetness as the test material, provided in individual sachets containing 1.4 ml.

Placebo Tolerability Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is willing and able to participate in the study for the required duration, understand and provide signed informed consent, and agrees to undergo all protocol activities.
• Subject is proficient in reading, writing, and speaking English.
• Subject is able to complete all required electronic Daily Bowel Movement and Symptoms Questionnaire, daily medication reconciliation surveys (Screening, Product Phase, and Product/Placebo Phase), bi-weekly PAC-SYM and PAC QOL questionnaire, and monthly Study Participant Global Assessment questionnaire entries during the 2 week Screening Phase assessment period and for the duration of the study (ie, the 8 week randomized Product/Placebo Phase, 4 week open label Product Phase and the 2 week Follow up Phase).
• Males or females between 18 and 75 years of age (inclusive), with a BMI ≥ 19 and \< 35 kg/m2. Females must not be pregnant or lactating.
• Female Subjects of non childbearing potential whether surgically sterile or postmenopausal.
• Females who are still menstruating must be able to differentiate the abdominal symptoms associated with CIC from those associated with their menses (otherwise protocol assessments of these symptoms may be confounded).
• Male and female Subjects of childbearing potential must agree to use adequate contraception from the time of informed consent to 2 weeks after receiving the last dose of study product.
• Subject meets the Rome IV functional constipation criteria as modified for this study for ≥ 3 months prior to the Screening Call. The Rome IV criteria as modified for this study, requires the following:
• Subject reports that loose stool is rarely present without the use of laxatives.
• Subject does not meet the Rome IV criteria for IBS C.
• Subject does not use manual maneuvers (eg, digital evacuation, support of the pelvic floor) to facilitate defecations.
• Subject reports a history of \< 3 complete spontaneous bowel movements per week.
• Subject reports ≥ 2 of the following:
• i. Straining during ≥ 25% of defecations ii. Lumpy or hard stool in ≥ 25% of defecations iii. Sensation of incomplete evacuation for ≥ 25% of defecations iv. Sensation of anorectal obstruction/blockage for ≥ 25% of defecations
• Subjects who meet the modified Rome IV criteria based on history must also demonstrate the following during the 2 week Screening Phase diary assessment period:

You may not qualify if:

• Subject has not maintained a stable diet for ≥ 30 days prior to the Screening Call or is unwilling to maintain a stable diet during the study.
• Subject has had a surgical procedure requiring general anesthesia \< 60 days before the Screening Call.
• Subject has had a colonoscopy in the past 30 days or is scheduled for colonoscopy within the next 4 months and is unable/unwilling to postpone until the completion of study participation.
• Subject has a history of cancer (other than basal cell carcinoma of the skin) unless the malignancy has been in a complete remission without maintenance therapy (eg, chemotherapy, radiation, surgery) for ≥ 5 years prior to the Screening Call.
• Subject has any acute or chronic concomitant illness that could confound outcome assessments for this study, including, but not limited to:
• Known history of ulcerative colitis, Crohn's disease, colon cancer, current stomach ulcers, pancreatitis, diverticulitis.
• Known history of acute or chronic HBV, HCV, or HIV infection.
• Known or suspected alcoholism, drug addiction, or significant drug abuse within 1 year of the Screening Call.
• Subject has any known medical condition, clinical signs and symptoms, vital signs, abnormal laboratory, or other testing, considered clinically significant by the Investigator, that could interfere with the subject's participation in and completion of the study including, but not limited to:
• Uncontrolled hypertension.
• Diabetes uncontrolled by diet (ie, requiring oral medication or insulin).
• Previous anaphylactic reaction to any medication.
• History of adrenal disease, diabetic nephropathy, or gastroparesis.
• Uncontrolled hypothyroidism.
• Untreated mental disorder

Sponsors & Collaborators

• Microbiome Health Sciences: lead

Study Sites (1)

Remote Study - by phone and online

Manassas, Virginia, 20109, United States

Location

Study Officials

• Peter Swann, MD

  Microbiome Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 200 subjects with CIC who meet all eligibility criteria will be randomized in a 1:1 ratio, with equal numbers of each in each successive group of 50 subjects, to receive either MHS 1031 \[1 g (1.4 ml) per day\] or 1.4 ml of placebo (1:1) for 8 weeks (Product/Placebo Phase). Upon completion of the 8 week Product/Placebo Phase, Subjects will enter a 4 week open label Product Phase, during which all subjects will receive MHS 1031.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 22, 2021
• Study Start: September 23, 2021
• Primary Completion: June 12, 2022
• Study Completion: June 12, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)