Study on the Effect of Rhubarb Extract on Stool Frequency and Biological Markers of Intestinal Function in Seniors With Low Defecation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Randomized double-blind clinical study versus placebo evaluating the effect of
      supplementation with rhubarb extract on stool frequency and biological markers of intestinal
      function in seniors with a low number of defecations per week
    

Detailed description: 
      The main objective was to evaluate the effect of rhubarb extract supplementation on improving
      intestinal transit in subjects with a low number of defecations per week.

      The secondary objectives are to assess: changes in the appearance of the stool; the evolution
      of the quality of life; the evolution of biological markers of intestinal function; the
      evolution of the intestinal microbiota; the evolution of low-grade chronic inflammatory
      markers; the evolution of endotoxemia; the evolution of oxidative stress; the relief
      experienced; subject satisfaction; the evolution of safety dosages; subject compliance.

      The main efficacy criterion is the improvement in intestinal transit assessed by the
      frequency of stool emissions reported daily from D-14 to D 30.

      The secondary endpoints correspond to the evolution of the aspect of the stools evaluated by
      the Bristol Stool Scale and the evolution of the quality of life evaluated by the SF-12.

      They also correspond to the relief of the subjects evaluated on the PGII scale, to the
      tolerance of the product over the entire study period and in particular the occurrence of
      diarrhea and to the description of satisfaction on a Likert scale.

      Regarding the biological assays, they correspond to:

        -  for biological markers of intestinal function to those specific to intestinal transit,
           i.e. active GLP-1, total GIP total PYY, PP (DPPIV substrates), Leptin, Insulin, by blood
           samples at D0 and D30 and that specific for permeability intestinal or claudin-3 by
           urine samples at D0 and D30;

        -  for the microbiota, analysis of bacterial taxa by PCR and metagenomics carried out on
           faecal samples collected on D0 and D30;

        -  for chronic low-grade chemokine inflammatory markers, Prostaglandins, interleukins, pro-
           and anti-inflammatory cytokines, ultra-sensitive CRP by blood samples at D0 and D30;

        -  for the measurement of endotoxaemia in the analysis of circulating LPS, TRL2 and 4 by
           blood samples on D0 and D30;

        -  for the measurement of oxidative stress to the ROS and NADPH oxidase content by blood
           serum samples at D0 and D30;

        -  for the safety assays for the lipid profile, NFS, glycaemia, kalemia, transaminases by
           blood samples on D0 and D30.

      The studied product is a food supplement composed of a rhubarb extract standardized,
      characterized and optimized in order to improve these functional effects on the intestinal
      system (regulation of the local inflammatory system, microflora, peristalsis, etc.) at 2
      different doses. The food supplement comes in the form of a film-coated tablet. The
      comparator product was a placebo with an appearance strictly identical to the verum and
      contains only excipients.
    

Intervention name(s): single dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract; placebo coated tablet; double dose coated tablet Fruits & Fibres Rhubarbe with standardised rhubarb extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): coated tablet with a single dose of standardised rhubarb extract; coated tablet without active principle; coated tablet with a double dose of standardised rhubarb extract
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blind clinical study versus placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment