| Eligibility |
Inclusion Criteria:
1. Male or female 18-75 years (inclusive) of age
2. BMI 18.5-29.9 ±1 kg/m2
3. Abdominal bloating intensity score =5 and at least two days of bloating over the 2
weeks prior to screening (assessed at screening by Abdominal Bloating questionnaire)
4. Participants categorized as 'high bloaters' as defined by an average bloating score =
5 during the run-in period assessed at baseline by question 3 of the Modified Daily
Abdominal Discomfort, Gas, and Bloating Questionnaire, AND/OR, participants
categorized as 'high frequency bloaters' as defined by greater than 7 days of high
bloating (defined above) during the run-in period.
- For females, this should not include abdominal discomfort or bloating experienced
during menstruation, if such symptoms occur due to menstrual cycle females should
go through another run-in period.
5. If female, participant is not of child bearing potential, which is defined as females
who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are
post-menopausal (natural or surgically with > 1 year since last menstruation) OR
Females of childbearing potential must agree to use a medically approved method of
birth control and have a negative urine pregnancy test result. Acceptable methods of
birth control include:
- Hormonal contraceptives (stable for 1 month) including oral contraceptives,
hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing),
injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant
System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing
to heterosexual partner(s)
- Vasectomy of partner (shown successful as per appropriate follow-up)
6. Healthy as determined by laboratory results, medical history, and physical exam
7. Agrees to abstain from consuming unpasteurized bacteria-fermented foods including
cheese and yogurt for 1 week prior to screening visit and throughout the study
8. Agrees to abstain from using fiber supplements 2 weeks prior to screening and for the
duration of the study
9. Agrees to maintain current dietary habits and activity/training levels for two weeks
prior to baseline and for the course of the study
10. Agrees to avoid probiotics for one week prior to screening and for the course of the
study
11. Willingness to complete all the study requirements and attend all clinic visits.
12. Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
1. Females who are pregnant, breastfeeding, or planning to become pregnant during the
course of the trial
2. History of chronic inflammation or structural abnormality of the digestive tract
(inflammatory bowel disease, duodenal or gastric ulcer, intestinal obstruction, or
symptomatic cholelithiasis)
3. Nocturnal and/or progressive abdominal pain (abdominal pain that increases in
intensity and is consistent on regular basis)
4. Significant weight loss over the past 3 months (significance to be determined by the
Qualified Investigator)
5. Type 1 and type 2 diabetes
6. History of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis,
gastric retention or obstruction, bowel resection, rectocele, or colostomy
7. Cancer except skin cancers completed excised with no chemotherapy or radiation
following and with a negative follow up.
8. Diagnosis of adenomatous polyposis, irritable bowel syndrome, chronic gastritis or
functional dyspepsia, crohn disease, and celiac disease Renal or hepatic insufficiency
9. Gastrointestinal bleeding or acute infection
10. Immunodeficiency
11. History of organ transplant
12. Use of antibiotics within 4 weeks of randomization Routine (at least 3 times per week)
consumption of probiotic or prebiotic supplements or supplemented foods and are
unwilling to stop at least one week prior to screening and throughout the study
13. Use of immunosuppressant drugs
14. Change in anti-psychotic medication within 3 months of randomization
15. Abdominal surgery within 6 months of randomization
16. Plan to donate blood during the study or within 30 days of completing the study
17. Participation in a clinical research trial within 30 days prior to randomization
18. Allergy or sensitivity to study supplement or placebo ingredients
19. Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the last 6
months
20. Use of Medicinal Marijuana
21. Cognitively impaired and/or unable to give informed consent
22. Unstable medical conditions
23. Clinically significant abnormal laboratory results at screening
24. Any other condition which in the Qualified Investigator's opinion may adversely affect
the volunteer's ability to complete the study or its measures or which may pose
significant risk to the volunteer
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