Align® Bifidobacterium 35624™ DemonstratedClinical Efficacy 1*
OVER 60% OF PATIENTS REPORTED SIGNIFICANT RELIEF FROM IBS SYMPTOMS AFTER 4 WEEKS1*†
- 20% more patients reported adequate relief of global IBS symptoms after 4 weeks of Align® Bifidobacterium 35624™ treatment compared to placebo1†
- Significant improvements were seen in symptoms of abdominal discomfort or pain and bloating or distension1
†Patients responded “yes” or “no” to the following question: Compared to the way you felt before beginning the medication, have you had adequate relief of your IBS symptoms?
Align® Bifidobacterium 35624™ Alleviated IBS Symptoms1
- • Patients reported significantly less IBS symptoms after Align treatment vs. Placebo1*
Align Bifidobacterium 35624™ Clinical Study Design1
To investigate the efficacy and safety profile of Bifidobacterium 35624™ for treatment of female subjects with Irritable Bowel Syndrome (IBS)
Randomized, double-blind, placebo-controlled, multi-centre (20 centres) study > 2-week run-in; 4-week treatment; 2-week follow-up; N=362
- • 1x1010 Bifidobacterium 35624 (1x109 - 1x1011)
- • 1x108 Bifidobacterium 35624 (1x107 - 1x109)
- • 1x106 Bifidobacterium 35624 (1x105 - 1x107)
- • Placebo
Bifidobacterium 35624™ Established Safety
Bifidobacterium 35624™ has a proven safety profile that is comparable to placebo 1,2
- • Published Studies show Bifidobacterium 35624 is well-tolerated
- • Excellent safety and tolerability profile, similar to placebo
* A randomized, double-blind, placebo-controlled, multi-centre (20 centres), dose ranging study that investigated the efficacy and safety profile of Bifidobacterium 35624 in the treatment of 362 female subjects with Irritable Bowel Syndrome (IBS). Study included: 2-week run-in; 4-week treatment; 2-week follow-up period. Dosage range: 1x1010 Bifidobacterium 35624 capsule (1x109 - 1x1011), 1x108 Bifidobacterium 35624 capsule (1x107 - 1x109), 1x106 Bifidobacterium 35624 capsule (1x105 - 1x107), placebo (capsule). Primary endpoint was abdominal pain/discomfort at week 4.
† Please consider how you felt in the past week in regard to your IBS, in particular your general well being and symptoms of abdominal discomfort or pain, bloating or distension and altered bowel habit.
§ Assessed using a 6-point scale where 0=no symptoms and 5=very severe symptoms.
|| Sum of scores for abdominal pain/discomfort, bloating/distension, and bowel habit satisfaction.
- Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated Probiotic Bifidobacterium infantis 35624 in Women with Irritable bowel Syndrome. Am J Gastroenterol. 2006;101:1581-1590.
- O’Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology 2005;128:541-551.
- Skokovic-Sunjic D. The Clinical Guide to Probiotic Products Available in Canada - 2019 Edition. Indications, Dosage Formats, and Clinical Evidence to Date. Available at: www.probioticchart.ca
FOR INFORMATION ON ALIGN DOSING, CLICK HERE
ALIGN HAS LEVEL 1 (HIGHEST LEVEL) RATING OF CLINICAL EVIDENCE ACCORDING TO THE 2020 CLINICAL GUIDE TO PROBIOTIC PRODUCTS AVAILABLE IN CANADA5
‡Among Doctors and Gastroenterologists who recommended a brand of probiotic in ProVoice surveys 2015 to 2020.