title: Single-blind follow-up study on the effectiveness of a symbiotic preparation in irritable bowel syndrome.
abstract: OBJECTIVE
  Experimental and clinical studies have shown that a novel symbiotic (known as SCM-III) exerts a beneficial effect on gut translocation and local and systemic inflammatory and microbial metabolic parameters. The present investigation was a preliminary trial on the effectiveness of SCM-III for irritable bowel syndrome (IBS).
  
  
  METHODS
  Sixty-eight consecutive adult patients with IBS who were free from lactose malabsorption, abdominal surgery, overt psychiatric disorders and ongoing psychotropic drug therapy or ethanol abuse were studied prospectively and divided into 2 groups that were comparable for age, gender, body size, education and pattern of presenting symptoms. The 2 groups were blindly given for 12 weeks either SCM-III 10 mL t.i.d or the same dosage of heat-inactivated symbiotic.
  
  
  RESULTS
  Treatment with SCM-III was 'effective' or 'very effective' in more than 80% of the patients (P < 0.01 vs baseline values and control). Less than 5% reported 'not effective' as the final evaluation compared with over 40% of patients in the control group. After 6 weeks of treatment, a significant improvement of pain and bloating was reported in the treatment group compared with control and baseline values. There was also a benefit for bowel habits, mostly for patients with constipation or alternating bowel habits. No overt clinical or biochemical adverse side-effects were recorded.
  
  
  CONCLUSIONS
  Compared with baseline values and the control group, SCM-III resulted in a significant increase in lactobacilla, eubacteria and bifidobacteria, which suggests that some selected IBS patients could benefit substantially from symbiotics, but the treatment may need to be given on a cyclic schedule because of the temporary modification of the fecal flora.
authors.affiliation: TMC Hospital, Shizuoka, Japan.
authors.forename: J
authors.initials: J
authors.lastname: Tsuchiya
authors.forename: R
authors.initials: R
authors.lastname: Barreto
authors.forename: R
authors.initials: R
authors.lastname: Okura
authors.forename: S
authors.initials: S
authors.lastname: Kawakita
authors.forename: E
authors.initials: E
authors.lastname: Fesce
authors.forename: F
authors.initials: F
authors.lastname: Marotta
mesh_terms: D000328:Adult; D000368:Aged; D001419:Bacteria / Q000254:growth & development*; D001644:Bifidobacterium / Q000254:growth & development*; D003248:Constipation / Q000209:etiology / Q000628:therapy; D005243:Feces / Q000382:microbiology; D005260:Female; D006801:Humans; D007422:Intestines / Q000382:microbiology; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D007779:Lactobacillus acidophilus / Q000254:growth & development*; D008297:Male; D008875:Middle Aged; D019936:Probiotics; D016037:Single-Blind Method; D016896:Treatment Outcome