Trial

Participants

Method

Probiotic Administration

Control Group

Outcome Definitions

Jadad Quality Test

Malchow 1997

N = 28. Adults with active CD (CDAI > 150) on a steroid- tapering regimen until remission achieved (CDAI ≤ 150)

Single Center RCT; double blind; Placebo- controlled

Maintenance of remission: E. coli (mutaflor; 200 mg daily)

Maintenance of remission: placebo

Proportion of patients clinical relapsing (CDAI > 150). Decrease in steroid requirements. Adverse events.

3

Prantera 2002

N = 32 Adults (22 - 71 years) with confirmed remission after surgery. No antibiotics > 10 days post-surgery or steroids 30 days post-surgery.

Single Center RCT; double blind; Placebo- controlled

Maintenance of remission: Lactobacillus rhamnosus strain GG (12 billion c.f.u. in 4.92 g/day)

Maintenance of remission: placebo

Clinical relapse (CDAI

>150) confirmed by endoscopic recurrence (Rutgeerts scoring system of grade 2 or higher). Adverse events.

5

Schultz 2004

N = 11 Adult patients with moderate to active CD (CDAI > 150) on a steroid-tapering regimen. Maintenance of remission evaluated, with relapse defined as an increase in CDAI of >100 points.

Single Center RCT; double blind; Placebo- controlled

Maintenance of remission: Lactobacillus rhamnosus strain GG (20 billion c.f.u./day)

Maintenance of remission: placebo

Clinical relapse defined as an increase of >100 points in CDAI score.

3

Van Gossum 2007

N = 70 Patients with CD were enrolled prior to elective ileocaecal resection and randomly assigned after surgery to daily treatment

Multicenter RCT; double blind; Placebo- controlled

Maintenance of remission: lactobacillus johnsonii, LA1 (10¹⁰ c.f.u/day)

Maintenance of remission: placebo

Clinical relapse defined as Crohn’s disease activity index > 150 with an increase of ≥70 over baseline

5

Steed 2010

N = 24 Adults with CD (CDAI 150‐450)

Single Center RCT; double blind; Placebo- controlled

Maintenance of remission: 2 × 10¹¹ freeze-dried Bifidobacterium longum and 6 g Synergy I (Orafti, Tienen, Belgium) bid

Maintenance of remission: placebo

Clinical relapse (increase in CDAI ≥ 100, CDAI

score > 450, steroid prescription, hospitalization, surgery)

5

Guslandi 2000

N = 32 Patients with Crohn’s disease in clinical remission (CDAI < 150) for at least 3 months. No immunosuppressives or steroids 3 months prior to entry.

Single Center RCT; investigator blind

Maintenance of remission: Reduced mesalazine (Pentasa 2 g/day) plus the yeast Saccharomyces boulardii (1 g/day).

Maintenance of remission: mesalazine (Pentasa, 3 g/day)

Clinical relapse (CDAI

>150) with an increase of 100 points above the baseline for >2 weeks. Adverse events.

2

Bourreille 2013

N = 165 Adults in the acute phase of the disease. Patients were treated with corticosteroids or budesonide and/or aminosalicylates according to the preference of each investigator and then randomized 4 weeks later after a remission had been obtained. Remission was defined by a CDAI < 150.

Multicenter RCT; double blind; Placebo- controlled

Maintenance of remission: Oral S boulardii 1 g/day

Maintenance of remission: placebo

Relapses were defined by a CDAI higher than 220 points, by a CDAI between 150 and 220 with an increase of at least 70 points over the baseline value, or by the need for a surgical procedure or the need to begin a medical treatment specifically for CD

5

Marteau 2006

N = 98 Patients were eligible if they had CD and undergone surgical resection of <1 m, removing all macroscopic lesions within the past 21 days.

Multicenter RCT; double blind; Placebo- controlled

Maintenance of remission: Lactobacillus johnsonii LA1 (2 × 10⁹ c.f.u/day)

Maintenance of remission: placebo

Clinical relapse defined as Crohn’s disease activity index ≥ 200

5

Desreumaux 2010

N = 85 CD patients in remission after curative ileocolonic resection

RCT; double blind; Placebo- controlled

Maintenance of remission: Lactobacillus casei (6 × 10 E10 cfu/day)

Maintenance of remission: placebo

Clinical recurrence defined as Crohn’s disease activity index > 150

3

Zocco 2003

N = 23 Adults with CD in remission as defined by CDAI < 150

RCT; unblinded; Maintenance- controlled

Maintenance of remission: Lactobacillus rhamnosus strain GG (18 billion viable bacteria/day) and mesalazine (2.4 g/day)

Maintenance of remission: mesalazine (2.4 g/day)

Clinical relapse defined as Crohn’s disease activity index > 150

2

Campieri 2000

N = 40 Adults with CD in remission after surgery

Single Center RCT; physician blind

Maintenance of remission: Rifaximin (1.8 g/day for 3 months) followed by VSL#3 (6 g/day of 300 billion bacteria for 9 months)

Maintenance of remission: mesalazine 4

g/day for 12

months.

Severe endoscopic recurrence as measured by Rutgeerts scoring system of grade 3 or higher. Adverse events.

1

Fedorak 2015

N = 120 Participants were 16 years of age or older with a radiologic, endoscopic, or surgical diagnosis of Crohn’s disease of at least 3-month duration and had recently undergone ileocolonic surgical resection with a small-intestine- to-colon anastomosis.

Multicenter RCT; double blind; Placebo- controlled

Maintenance of remission: VSL#3 (900 billion viable lyophilized bacteria) sachet 2/day

Maintenance of remission: placebo

Severe endoscopic recurrence as measured by Rutgeerts scoring system of grade 3 or higher.

5