Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This randomized, double-blind, controlled clinical trial among healthy volunteers with
      infrequent bowel movements but not severe constipation evaluate the effects of a
      supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per
      week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides
      - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion
      / sachet and a placebo group treated with a comparative product hat looked strictly identical
      to the verum and contained only excipients (60% maltodextrin / 40% sucrose).

      The claim investigated corresponds to the section of the new EFSA (European Food Safety
      Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".
    

Detailed description: 
      Few studies have been made in France of the epidemiology of constipation although it is a
      frequent reason for visits to the doctor or for seeking advice from pharmacists. The
      prevalence of constipation in European and North American populations is reportedly of the
      order of 15% on average and it is 2.2 times more frequent among women than men. Hammond and
      Harari show there is an increased frequency of constipation from the age of 50 years onwards
      and that it substantially impacts quality of life. This can be explained in part by
      significant changes in the workings of the gastro-intestinal system in the course of normal
      ageing with reduced numbers of bifidobacteria in the gut.

      These disorders are a major reason for taking oral and local drugs that are not without their
      side-effects and entail substantial healthcare costs. lifestyle rules combining appropriate
      fluid intake, regular physical activity and a high-fibre diet should be systematically
      recommended to such patients. "Symbiotic" dietary supplements combining probiotics and
      prebiotics may also be recommended provided that their effects have been properly validated.
      The symbiotic combination proposed in this clinical study is made up of
      fructo-oligosaccharides (FOS) sold as Actilight FOS (Beghin Say) and bifidobacteria BB12.
      Each of these components has been the subject of numerous studies showing improved intestinal
      transit especially in the elderly. A recent meta-analysis of the main studies published in
      Medline, Embase and The Cochrane Library has concluded that symbiotic with FOS and probiotics
      have a positive effect on bowel movement frequency and stool consistency.

      The change in European regulations requires that clinical studies be conducted to secure EFSA
      claims for these dietary supplements. Such studies should also show an objective clinical
      benefit and factors such as a dose-dependent effect and/or the modification of biological
      markers that might confirm any such positive effect.

      This randomized, double-blind, controlled clinical trial among healthy volunteers with
      infrequent bowel movements but not severe constipation serves this purpose. The claim
      investigated corresponds to the section of the new EFSA guidance of 2016 entitled "Claims on
      maintenance of normal defecation".

      The primary endpoint of this trial is to evaluate the effect of supplementation in symbiotic
      on intestinal transit of subjects with few bowel movements per week.

      The secondary endpoints are to evaluate:

        -  both clinical criteria such as changes in stool appearance, quality of life and mood,
           relief and satisfaction of participants;

        -  and biological criteria such as changes in markers of gut function, low-grade chronic
           inflammation markers and gut microbiota markers.

      The safety of product use and compliance are also evaluated.
    

Intervention name(s): VES002; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.; The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For each subject enrolled in the trial, the planned length of the trial was 44 days composed of a 14 day period at the beginning of the study without taking the trial product and a 30 day period when it was taken. The trial included three visits to the CEN Experimental Centre at D-14, D0 and D30. The product was taken from D1 onwards, the day after the enrolment visit.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Constipation; Probiotic; Prebiotic