| Eligibility |
Inclusion Criteria:
1. 18 to 65 years old
2. Healthy
3. On no medication, or on stable doses of medications which will not be changed over the
course of the study
4. Willingness to maintain their usual dietary habits and physical activity
5. Willing to discontinue consumption of fermented foods or probiotics (such as kombucha,
yogurts with live, active cultures, or probiotic supplements) for the duration of the
study.
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule and study tasks and
interventions
8. Willing to fast for at least 8 hours before the 2 intake visits (Visit 1 and Visit 2)
Exclusion Criteria:
1. History of a small intestine obstruction of symptoms of an intermittent small
intestine obstruction (i.e., recurrent abdominal pain, distention, nausea and
vomiting).
2. Pregnant or breastfeeding or planning on becoming pregnant during study timeline.
3. Use of other investigational product within 3 months of start of the study.
4. Suffering from immune disorders or with possible immune deficient status
5. Allergy to soy or milk.
6. Prior gastrointestinal surgery which has altered the anatomy of the esophagus, stomach
or small or large intestine (exceptions include appendectomy or cholecystectomy more
than 3 months prior to enrollment).
7. Use of any medications in the previous 7 days that could substantially alter
gastrointestinal motor function (e.g. opioids, prokinetics, anticholinergics,
laxatives), acidity (PPI, H2RA), or integrity (NSAIDs, oral steroids).
8. Body Mass Index (BMI) > 38.
9. Previous history of gastric bezoar or gastroparesis.
10. Any abdominal or pelvic surgery within the past 3 months.
11. Known history of inflammatory bowel disease and/or Crohn's disease.
12. History of diverticulitis, diverticular stricture, or other intestinal strictures.
13. History of abdominal or pelvic radiotherapy.
14. History of dysphagia, eosinophilic esophagitis, esophageal stricture, or other
swallowing disorder.
15. Cardiovascular, endocrine, renal or other chronic disease likely to affect motility.
16. Colon cleansing prep for 1 month before the first visit, or during the study.
17. Use of antibiotics, prebiotics, herbal supplements, or probiotics for 2 weeks before
the first visit, or during the study.
18. < 2 bowel movements per week.
|
