Multistrain ProbioticMultistrain Probiotic for Functional Constipation

Inclusion Criteria:

1. Age 18 to 65 years
2. Body mass index 18.5 to 39.9 kg/m2
3. Meets the criteria below over the last 3 months with symptom onset at least 6 months prior (Rome III definition of functional constipation 1):

• Meets 2 or more of the following criteria:

• Straining during at least 25% of defecations
• Lumpy or hard stools in at least 25% of defecations
• Sensation of incomplete evacuation for at least 25% of defecations
• Sensation of anorectal obstruction/blockage for at least 25% of defecations
• Manual maneuvers to facilitate at least 25% of defecations (e.g. digital evacuation, support of the pelvic floor)
• Fewer than three defecations per week
• Loose stools are rarely present without the use of laxatives
• Insufficient criteria for irritable bowel syndrome

4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
5. Able to understand the nature and purpose of the study including potential risks and side effects
6. Willing to consent to study participation and to comply with study requirements
7. Successful completion of 2-week run-in period, defined as:

• Must meet the Rome III definition of functional constipation during this 2-week period
• Completion of all study-related questionnaires

Exclusion Criteria:

1. Major gastrointestinal complication (e.g. Crohn's disease, ulcer, cancer)
2. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
3. Clinically significant systemic disease (e.g. cancer, diabetes, CAD)
4. Consumption of probiotics or prebiotics within 2 weeks of randomization
5. Antibiotic use within 4 weeks of randomization
6. Laxative or other constipation medication use within 2 weeks of randomization
7. Eating disorder
8. Known allergies to any substance in the study product, including lactose intolerance
9. Pregnant or breastfeeding women
10. History of alcohol, drug, or medication abuse
11. Participation in another study with any investigational product within 3 months of randomization
12. Any condition that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes