Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation

Inclusion Criteria:

• 1.18 to 85-year-old men and women. 2. People with moderate to severe functionalconstipation according to Rome IV criteria.

The Rome IV criteria for functional constipation are as follows:

1. Must include two or more of the following:

• Straining during more than one-fourth (25%) of defecations;

• Lumpy or hard stools (BSFS 1-2) more than one-fourth (25%) of defecations;

• Sensation of incomplete evacuation more than one-fourth (25%) of defecations;

• Sensation of anorectal obstruction/blockage more than one-fourth (25%) ofdefecations;

• Manual maneuvers to facilitate more than one fourth (25%) of defecations (e.g.,digital evacuation, support of the pelvic floor);

• Fewer than 3 spontaneous bowel movements per week;

2. Loose stools are rarely present without the use of laxatives.

3. Insufficient criteria for irritable bowel syndrome Criteria fulfilled for the lastthree months with symptom onset at least six months prior to diagnosis.

Severity of constipation:

1. Mild: The symptoms are mild and do not affect daily life. Normal BMs can be restoredthrough overall adjustment and medication use in a short time.

2. Moderate: The symptoms are between mild and severe symptoms.

3. Severe: The symptoms are severe and persistent, seriously affecting work and life,and requiring medications, and medications cannot be stopped, or medications areineffective.

4. People who had a colonoscopy within three years before screening and hadnegative results, or whose colonoscopy results are judged by the investigatoras mild anomalies, but the cause of their constipation cannot be explained. Ifthe colonoscopy report is unavailable, the study physician will determine if acolonoscopy is needed. If the subjects undergo a colonoscopy after signing theICF, they will not enter the treatment period until their BMs return to thebaseline level (which takes about 1-4 weeks).

5. People had colonic polyps and a polypectomy (except for endoscopic submucosaldissection (ESD)). Those with a polyp ≤1 cm can be enrolled one month after thepolypectomy. Those with a polyp >1 cm can be enrolled three months after thepolypectomy.

6. People who consent to participate in this trial, can communicate with theinvestigator, understand and comply with the relevant procedures andrequirements during the study (including completing study questionnaires ontime, being treated and visited as scheduled, and undergoing relevantexaminations), and voluntarily sign the ICF.

Exclusion Criteria:

1. People who are not eligible for surgery or refuse to undergo any abdominalsurgery.

2. People with known or suspected gastrointestinal obstruction, stenosis,diverticulum, bleeding, malformation, and fistula.

3. People allergic to polymeric materials.

4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers.

5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions,ulcers, and lesions with bleeding tendencies.

6. People with dysphagia.

7. People with severe depression and anxiety and severe acute gastrointestinallesions.

8. People who had gastrointestinal surgery or a history of surgery that changedthe structure of the gastrointestinal tract (except for appendectomy) or peoplewho underwent gastrointestinal ESD in the past three months.

9. People with severe hemorrhoids (patients with grade III-IV hemorrhoidsaccording to the Clinical Practice Guidelines for the Management of Hemorrhoidsof the American Society of Colon and Rectal Surgeons).

10. People who plan to undergo MRI in the near future.

11. Pregnant women or women with pregnancy plans in the next year.

12. People with other conditions, so the investigator considers them not eligiblefor this study.