The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

Inclusion Criteria:

1. Age 22-70 years old

2. BMI >18.5 and <35 kg/m2

3. Rome III criteria for functional constipation or IBS-C

4. Continued IBS-C or CIC throughout Run-in period

5. Compliant with reporting during Run-in (confirm the presence of constipation during
the 7-day Run-in baseline period; patients are required to report an average of <3
continuous spontaneous bowel movements [CSBMs] and ≤6 spontaneous bowel movements
[SBMs] per week via the interactive web response system).

6. Ability to follow verbal and written instructions

7. Ability to record daily bowel habits, including frequency, stool consistency (BSFS),
straining (EoPS), completeness of evacuation, and Patient Reported Outcomes (PROs)
(abdominal discomfort, severity of constipation, bloating, overall relief)

8. Informed consent form signed by the subjects

Exclusion Criteria:

1. History of loose stools

2. History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel
syndrome (IBS-M)

3. Non-compliance with reporting during Run-in

4. Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage
of a prohibited medication during the Run-in period

5. Patients reporting watery stools for any SBM (Type 7 on the Bristol Stool Form Scale
[BSFS]) or loose (mushy) stools for >1 SBM (Type 6 on the BSFS) in the absence of
laxatives during Run-in

6. GI motility obstruction or GI tract structural abnormality

7. Current use of prescribed or illicit opioids

8. History of pelvic floor dysfunction

9. Need for manual maneuvers in order to achieve a BM

10. History of GI lumen surgery at any time or other GI or abdominal operations within 60
days prior to entry into the study

11. History of high-dose stimulative or cathartic laxative abuse as judged by investigator
team

12. Neurological disorders, metabolic disorders, or other significant disease that would
impair their ability to participate in the study

13. Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis

14. BMI of <18.5 or >35 kg/m2

15. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing
potential) or lactation

16. Absence of contraception in females of childbearing potential

17. History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl
fumarate, raw cane sugar, gelatin, or titanium dioxide

18. Administration of investigational products within 1 month prior to Screening Visit

19. Exclusion of colonic inertia with symptoms of < 1 BM per 2 weeks

20. Subjects anticipating surgical intervention during the study

21. Known history of diabetes (type 1 or 2)

22. History of eating disorders including binge eating (except mild binge eater)

23. Supine SBP > 160 mm Hg and/or supine DBP > 95 mm Hg (mean of two consecutive readings)

24. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening
Visit

25. History of swallowing disorders

26. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)

27. History of gastric bypass or any other gastric surgery

28. History of small bowel resection (except if related to appendectomy)

29. History of gastric or duodenal ulcer

30. History of gastroparesis

31. History of abdominal radiation treatment

32. History of pancreatitis

33. History of intestinal stricture (e.g., Crohn's disease)

34. History of intestinal obstruction or subjects at high risk of intestinal obstruction
including suspected small bowel adhesions

35. History of malabsorption

36. History of sucrose intolerance

37. History of hepatitis B or C

38. History of human immunodeficiency virus

39. History of cancer within the past 5 years (except adequately-treated localized basal
cell skin cancer or in situ uterine cervical cancer)

40. Any other clinically significant disease interfering with the assessments of
Gelesis100, according to the Investigator (e.g., disease requiring corrective
treatment, potentially leading to study discontinuation)

41. HbA1c > 8.5% (> 69 mmol/mol)

42. Positive test for drugs in the urine

43. Any relevant biochemical abnormality interfering with the assessments of Gelesis100,
according to the Investigator

44. Antidiabetic medications within 1 month prior to Screening Visit (except stable dose
of metformin, ≤ 1500 mg/day, for at least 1 month in subjects with type 2 diabetes)

45. Medications requiring mandatory administration with meal at lunch or dinner

46. Anticipated requirement for use of prohibited concomitant medications

47. Implanted or externally worn medical device such as, but not limited to, a pacemaker,
infusion pump, or insulin pump