Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)
Condition: Constipation Chronic Idiopathic
MeSH terms: Constipation
Study type: Interventional

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.
    

Detailed description: 
      This study will be conducted as a multicenter, randomized, double blind, placebo controlled
      trial to evaluate the tolerability of MHS 1031 and tolerability of the formulated placebo.
      The study consists of a screening phase to establish eligibility and baseline values,
      followed by 3 distinct study periods.

      Subjects with CIC will be determined eligible for the study based on modified Rome IV
      criteria during a 2 week Screening Phase. 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. Subjects who complete the study will enter a 2-week
      Follow-up Phase, during which subjects will take neither placebo nor MHS 1031.

      During the study, tolerability will be assessed on the basis of Patient Reported Outcomes
      (PRO questionnaires), concomitant medication assessments, and assessment of adverse events.
      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.
    

Intervention name(s): MHS 1031; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): prebiotic syrup in individual sachets containing 1g (1.4 ml) of panosyl-isomaltooligosaccharides; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: CIC; microbiome; PIMO; Panosyl-isomaltooligosaccharides; prebiotic