Treatment Efficacy of Low FODMAP Versus Low Lactose Diet in IBS Patients
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS)
      patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect
      of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over
      trial with IBS patients.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder. It affects 10 - 20% of
      the adult population. Pharmaceutical therapy as bulking agents, anticholinergics,
      antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists
      recommend therefore dietary management. Most patients note that various foods elicit
      abdominal symptoms and therefore restrict their diet .

      The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet
      has currently the greatest evidence for efficacy in IBS. The rationale behind the LFD is the
      exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load,
      drag fluid into the small intestine and would be fermented by the colonic microbiome, both
      leading to abdominal distention and increased luminal influx. FODMAPs do not cause symptoms
      in healthy adults as they neither show these abnormalities in gut physiology nor suffer from
      visceral hypersensitivity .

      It is not known however whether change in symptoms is induced by a reduction in all FODMAPs
      or simply a single component as for example lactose. If there is a lactase deficiency, as it
      is the case in 2-20% of Central- / Northern Europeans, lactose cannot be hydrolysed and
      causes the above mentioned symptoms. Many IBS patients avoid lactose, even though only few
      have a lactase deficiency. Lactose intolerance but not lactase deficiency is more frequent in
      patients with IBS. The investigator wanted to examine if the demanding LFD is more effective
      than elimination of lactose alone.

      Our study, comparing in detail the effects of low FODMAP versus low lactose diet in IBS
      patients is a novelty, analysing a clinically highly relevant topic.
    

Intervention name(s): Low Lactose Diet; Low FODMAP Diet
Intervention type(s): Other; Other
Intervention description(s): First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.; First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment