C4PRE/PRO-BIOTICS

StudyParticipantsInterventions
Bittner 2005; Trial held in USA; parallel; trial; Setting: primary careInclusion & Exclusion criteria: not stated Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Not stated; Post infective: not post infective Age (range): 20–70yrs; Gender (M/F): 2:23; Comorbidities: none Weight, Length of time since presentation, duration of symptoms, ethnicity, socio-economic group
  1. 1x500mg Prescript-Assist capsule twice a day (stimulant); duration: 2 weeks; frequency/day: twice/day; amount 1gm/day (n=12)
  2. 1xplacebo capsule twice a day (placebo); duration: 2 weeks;frequency/day: twice day; amount 0gm/day (n=13)
Gade & Thorn 1989; Trial held in Denmark; parallel; trial; Setting: primary careInclusion & Exclusion criteria: Exclusions: Pregnant women, laxative, spasmolytic, antidiarrhoeal & ntibiotic treatment in week prior to participation. Type of IBS: Mixed; IBS definition: Authors’ def; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not post infective Age (range): Mean: 34 yrs(16–60); Gender (M/F): 12:42; Comorbidities: None Hamilton Miller review has assayed Paraghurt and estimated daily dose to be 8 x 10^6 CFU. IBS at least 6 months; implies that other IBS medication stopped
  1. 4 x Paraghurt tablet (freeze dried Streptococcus faecium) 4 times/day with food (softeners); duration: 4 weeks; frequency/day: 4times/day; amount 8 tablets/day ( dose estimated as 8 x 10^6 CFU/d) (n=32)
  2. 4 x placebo tablets 4 times/day (placebo); duration: 4 weeks; frequency/day: 4 times/day; amount 0g/day (n= 22)
Kajander 2005; Trial held in Finland; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Inc.s-lactose intolerance. Exc.s - pregnant, GI disease or other, surgery, dementia, antimicrobial medication during previous 2 months Type of IBS: Mixed; IBS definition: Rome I; Severity of IBS symptoms: Not stated; Bloating/flatus: Not stated; Post infective: Age (range): 45.5 (21–65); Gender (M/F): 24:79; Comorbidities: none Weight: BMI: 25.5kg/m2 Patients were allowed to continue other IBS medication (number not stated) Rome II also used. Sub groups Predefined.
  1. 1 capsule: L. rhamnosus LC705, Bacillus breve Bb99, P.freudenreichii ssp.shermanii JS (probiotics); duration: 6 months; frequency/day: once/day; amount 1 capsule/day (8–9 x 10^9 CFU/day) (n=52)
  2. 1 placebo capsule (cellulose, stearate, gelatin) (placebo); duration: 6 months; frequency/day: once/day; amount 1 capsule/day (n=51 )
Kim 2003; Trial held in USA; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion:No GI Disease, previous abdominal surgery, no use of medication that may alter gut motility, no over the counter medication and no antibiotic use within 2 weeks of recruitment. Type of IBS: Diarrhoea; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not post infective Age (range): 19–70; Gender (M/F): 8:10; Comorbidities: none Duration of symptoms: Median 8yrs range(2–41 yrs) in intervention grp. Median 6yrs Range(1–22 yrs) in control grp. Implies no concurrent IBS medication.
  1. VSL#3 powder sachet ( Bifidobacteriumx 3 strains, Lactobacillus x 4strains, Streptococcus x1 strain); miscible with yoghourt, soluble in water (probiotics); duration: 8 weeks; frequency/day: 1 sachet x twice/day; amount 45 x 10^10 lyophilized bacteria/day (n=12)
  2. 1 x identical looking placebo (starch) sachet x twice/day; miscible with yoghourt, soluble in water (placebo); duration: 8 weeks; frequency/day: twice/day; amount 0 lyophilized bacteria/day (n=13 )
Kim 2005; Trial held in USA; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: Pregnancy, previous abdominal surgery, long term antibiotic use or medication that may alter gut motility. Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: All patients; Post infective: not post infective Age (range): 21–75yrs; Gender (M/F): 3:45; Comorbidities: noneAll patients had visible distention >25% time for previous 12 m. Low dose antidepressants permitted during trial.
  1. VSL#3 powder sachet ( Bifidobacteriumx 3 strains, Lactobacillus x 4strains, Streptococcus x1 strain) in 6oz pasteurised yoghurt (probiotics); duration: 4 or 8 w (n=16, n=8 resp); frequency/day: 1 sachet twice/day; amount 45 x 10^10 lyophilized bacteria/day (n=24)
  2. 1 identical looking placebo sachet twice/day in 6oz yoghurt (placebo); duration: 4 or 8 w (n=9, n=15 resp); frequency/day: twice/day; amount 0 lyophilized bacteria/day (n=24)
Niedzielin 2001; Trial held in Poland; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Excl: when disorders excludable through abdominal ultrasound & rectosigmoidoscopy or colonoscopy Type of IBS: Mixed; IBS definition: Manning; Severity of IBS symptoms: mixed; Bloating/flatus: All patients; Post infective: not post infective Age (range): 45 (27–63yrs); Gender (M/F): 8:32; Comorbidities: none statedWeight: mean 63.5 kg(SD4.5) All patients had a previous history of IBS, treated with different medications and had been referred to secondary care because of problems with management.
  1. Fruit drink 5% oatmeal soup fermented with L plantarum 299V; concn 5 x10^7 CFU/ml (probiotics); duration: 4 weeks; frequency/day: twice/day; amount 400mls twice/day (i.e., 4 x 10^10 CFU) (n=20)
  2. Inactive fruit drink thsat looked, smelled and tasted the same as active fruit drink. (placebo); duration: 4 weeks; frequency/day: twice/day; amount 0 probiotic twice/day (n=20)
Niv 2005; Trial held in Israel; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: previous abdominal surgery, active organic GI disease, major psychiatric disorders Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: post infective Age (range): 45yrs; Gender (M/F): 18:36; Comorbidities: none Duration of symptoms: mean 6.7 (SD6.2) in Intervention. 9.2 (SD 11) in placebo. Other medications were continued; 20% received IBS medication.
  1. Tablets of L. reuteri ATCC 55730 with 1 x 10^8 CFU (probiotics); duration: 6 months; frequency/day: 2 times/day; amount 4/day for 7d then 2/day (i.e.mainly 2 x 10^8 CFU) (n=27)
  2. 4xidentical looking placebo tablets (placebo); duration: 6 months; frequency/day: twice/day; amount 0 probiotic/day (n= 27)
Nobaek 2000; Trial held in Sweden; parallel; trial; Setting: primary careInclusion & Exclusion criteria: Exclusion: pregnancy, previous abdominal surgery, mental disorders, organic GI diseases & other systemic disease. Antibiotic treatment of medication that may alter gut motility Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Postinfective: not post infective Age (range): 48 (21–78)yrs; Gender (M/F): 16:36; Comorbidities: None Patients recruited via newspaper advert. IBS medication was exclusion.
  1. 5% oatmeal soup fermented with Lactobacillus plantarum DSM 9843 with 5 x 10^7 CFU mixed with Rose-hip drink (probiotics); duration: 4 weeks; frequency/day: once daily; amount 400ml/day (5 x10^7 CFU) (n=30)
  2. Rose-hip drink (placebo); duration: 4 weeks; frequency/day: once daily; amount 400mls (n=30)
Olesen & Hoyer 2000; Trial held in Denmark; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: other chronic disease, abnormal dietray habits, regular use of strong analgesics/medication that may affect gut motility Type of IBS: Mixed; IBS definition: Manning; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not post infective Age (range): 45(SD13.1); Gender (M/F): 16:80; Comorbidities: noneWeight: mean 74.1 (SD 14.4)/71.5 (SD 13.3), duration of symptoms(mths) 159(SD141)/175(SD143)
  1. 10g sachet for 2 weeks then 20g for 10 weeks (osmotic); duration: 12 weeks; frequency/day: 10 gx twice day; amount 20g/day (n=52)
  2. 10g placebo sachet (placebo); duration: 12 weeks; frequency/day: twice day; amount 10g twice/day (n=46)
O’Mahony 2004; Trial held in Ireland; parallel; trial; Setting: mixedInclusion & Exclusion criteria: Exclusion: other GI disease, other systemic diseases, pregnancy, previous abdominal surgery, lactose intolerance or immune defficiency Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: Not stated; Bloating/flatus: Some patients; Post infective: not post infective Age (range): 44.3(18–73)yrs; Gender (M/F): 27:48; Comorbidities: NONE Patients from gastroenterology clinics and newspaper advertisement. All participants were white. Overall, IBS type was: 28% IBS-D; 26% IBS-C; 45% IBS-A. Patients were instructed not to take laxatives or antimotility agents.
  1. Lactobacillus salivarius UCC4331 (1 x 10^10) in malted milk drink (probiotics); duration: 8 weeks; frequency/day: once/day; amount 1x 10^10 live bacterial cells (n25)
  2. Malted milk drink (placebo); duration: 8 weeks; frequency/day: once/day; amount 0 x probiotic (n= 25)
  3. Bifidobacterium infantis 35624 in malted milk drink, duration: 8 weeks; dose/day: 1x 10^10 live bacterial cells; frequency/day: once (n=25)
Saggioro 2004; Trial held in Italy; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion: not stated Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not post infective Age (range): 40 (26–64); Gender (M/F): 31:39; Comorbidities: None Patients had been treated with drugs without success.:Lactobacillus plantarum LPO1 + Lactobacillus acidophilus LAO2 5x10^9(n=26)
  1. Lactobacillus plantarum LPO1 & Bifidobacterium Breve BRO 5x10^9sachet dissolved in water (probiotics); duration: 4 weeks; frequency/day: Twice daily; amount 5 x 10^9 bacteria/day (n=242)
  2. Placebo sachet dissolved in water (placebo); duration: 4 weeks; frequency/day: Twice/day; amount 0 probiotics/day (n=20 )Group B
Tsuchima 2004; Trial held in Italy; parallel; trial; Setting: secondary careInclusion & Exclusion criteria: Exclusion:lactose intolerance, previuos abdominal surgery, psychiatric disorders, pregnacy, Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not post infective Age (range): 46(36–65)yrs; Gender (M/F): 20:48; Comorbidities: None Mean number of years since diagnosis:6.1 yrs All patients had undergone a number of treatments without significant and lasting benefit
  1. SCM-III included Lactobacillus acidophilus1.25x10^6, Lactobacillus helveticus1.3x10^9 + bifidobacterium4.95x10^9 (probiotics); duration: 12 weeks; frequency/day: 10mls x 3 times/day; amount (n=34)
  2. SCM-III inactive preparation (heat-inactivated) (placebo); duration: 12 weeks; frequency/day: 3 times/day; amount 10mls x3 times/day (n= 34)
Whorwell 2006; Trial held in UK; parallel; trial; Setting: primary careInclusion & Exclusion criteria: Exclusion: over 55 without sigmoidoscopy in last 5 yrs, use of antipsychotic medication in last 3 months, previous major psychiatric disorder in past 2 yrs, pregnant, lactose intolerance, immunodeficiency, previous abdominal surgery. Type of IBS: Mixed; IBS definition: Rome II; Severity of IBS symptoms: mixed; Bloating/flatus: Some patients; Post infective: not stated Age (range): 41.9yrs(19–69); Gender (M/F): 0:362; Comorbidities: none Patients stratified by above/below 4 on Bristol Stool scale. Mean weight 71 kg (range 46–155)
  1. Bifidobacterium infantis 35624 1x10^6 in capsule (probiotics); duration: 4 weeks; frequency/day: once daily; amount 1x10^6/day (n= 90)
  2. Placebo capsule (placebo); duration: 4 weeks; frequency/day: once daily; amount og per day (n=90)
  3. 1x10^8 B. Infantis
  4. 1x10^10 B. Infantis

From: Appendix C, Characteristics of included studies

Cover of Irritable Bowel Syndrome in Adults
Irritable Bowel Syndrome in Adults: Diagnosis and Management of Irritable Bowel Syndrome in Primary Care [Internet].
NICE Clinical Guidelines, No. 61.
National Collaborating Centre for Nursing and Supportive Care (UK).
Copyright © 2008, Royal College of Nursing.

PubMed Health. A service of the National Library of Medicine, National Institutes of Health.