A Study to Evaluate the Effects of a Natural Supplement in Adults With Chronic Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Constipation is common in the general population, especially in women and in the elderly.
      Hard stool is a complaint often associated with constipation, which suggests that stool
      softening would provide a major benefit in the strategy of treatment.

      This investigative fibre product is primarily a soluble dietary fibre with added probiotics
      and a prebiotic. It is not digested in the small intestine and partly remains undigested by
      bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora,
      reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the
      improvement of intestinal motility.

      The objective of this study is to assess if this investigative, fibre product effects the
      number of bowel movements per week and if this in turn impacts quality of life and symptoms
      of constipation.
    

Detailed description: 
      Constipation is a common condition. Perception of a healthy bowel movement varies widely
      within and among populations but the Rome III Criteria is a standardised tool that diagnoses
      functional constipation on the basis of the following symptoms for the last 3 months with
      symptom onset at least 6 months prior to diagnosis:

        1. Must include two or more of the following:

             -  Straining during at least 25% of defecations

             -  Lumpy or hard stools in at least 25% of defecations

             -  Sensation of incomplete evacuation for at least 25% of defecations

             -  Sensation of anorectal obstruction/blockage for at least 25% of defecations

             -  Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital
                evacuation, support of the pelvic floor)

             -  Fewer than three defecations per week

        2. Loose stools are rarely present without the use of laxatives

        3. Insufficient criteria for irritable bowel syndrome

      Additional to being extremely uncomfortable, untreated constipation can lead to faecal
      impaction (with resulting faecal incontinence), particularly in elderly and confused people
      and is believed to be a risk factor for haemorrhoids (piles) and diverticular disease.
      However even without a medical diagnosis the undesired symptoms can reduce perceived quality
      of life and successful management may involve a number of factors. Standard treatment
      consists of disimpaction and the administration of laxatives to achieve a normal bowel habit
      of passing a soft stool without pain. The daily use of laxatives long term is often advised
      against as it can make your body dependent on them, causing your bowel to no longer function
      normally.

      Stool softening is a physician's first step in the management of chronic constipation.
      Psyllium has been shown to soften stools by increasing stool water content, far more than
      most common dietary fibres. It forms a soft gel which eases the stool along the lower
      digestive tract ready for evacuation. This bulkier faeces presses on the wall of the
      intestine, stimulating the muscles to contract and force the contents forward, a process
      known as 'peristalsis'. If there is insufficient fibre in the diet, the faeces will move more
      slowly and there will be more time for water to be absorbed from the ingested food into the
      rest of the body, leaving the faeces smaller and harder, which in turn is more difficult to
      move. Psyllium has the advantage of being much gentler than some common fibres (such as wheat
      bran) that can be irritating to a sensitive bowel.

      Studies using psyllium in a range of doses of 7g up to 24g a day show positive results in
      relation to increasing stool frequency and weight, and improving stool consistency, in turn
      improving associated abdominal pain and discomfort. These results were applicable in both
      adults and the elderly. Although psyllium works in a much more gentle natural way, in some
      studies it was seen to be superior to or comparative to commonly used laxatives.

      Probiotics had the added advantage of improving stool frequency and consistency and
      accompanying abdominal pain, most likely by their positive effects on the gut microflora
      often seen to be imbalanced in those with constipation. These effects were seen in infants,
      adults and the elderly with no adverse events such inducing loose stools.

      Lastly, inulin in a range of doses of 1.5g up to 50g a day was seen to improve not only
      beneficial bacteria counts but also bowel transit in infants, adults and the elderly and in
      one study was again seen to be more effective than a common laxative but without the side
      effects.

      This study aims to increase the body of scientific data on psyllium by way of a randomised,
      placebo-controlled study.
    

Intervention name(s): Natural Fibre Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Natural Fibre Supplement 2 doses per day for 4 weeks
Other intervention name(s): Lepicol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic; Functional; Constipation; less than 3 bowel movements per week