Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation

NCT04671264 | Completed DMC

• 1 other identifier: Vibrating Capsule II
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our study aimed to explore the clinical application of a newly developed smartphone-controlled multi-mode VC in the treatment of functional constipation (FC) on multicentres. Patients referred to gastroenterology outpatient of Changhai Hospital with FC and met the eligible criteria for more than 6 months and with spontaneous complete bowel movement (SCBM) less than 3 times per week within recent 3 weeks were eligible for this study. The study was discussed with patients who satisfied the enrolment criteria and provided written informed consents.

Conditions

Functional Constipation; Gastrointestinal Disease; Capsule Endoscopy

Keywords

Vibrating capsule; Functional Constipation; Spontaneous Bowel Movement; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with the increasing of SCBMs during treatment period≥1

  Based on diary card, researchers knew the total times of SCBMs during treatment period. The number divided by the treatment days and multiplied by 7 were the mean SCBMs per week in treatment period. Researcher compared the mean SCBMs per week with SCBMs in baseline period. "Spontaneous" suggested that no laxatives and enema were taken within 24 hours before defecation.

  Up to 6 weeks

Secondary Outcomes (8)

• Increase of SCBMs from baseline to treatment period

  Up to 6 weeks

• The proportion of patients with the increasing of SCBMs ≥1 in at least 4 weeks

  Up to 6 weeks

• Increase of SBMs from baseline to treatment period

  Up to 6 weeks

• Increase of PAC-QOL score from baseline to treatment period

  Up to 6 weeks

• The proportion of patients with the increasing of PAC-QOL score during treatment period≥1

  Up to 6 weeks

Study Arms (2)

VC group

EXPERIMENTAL

Vibrating capsule (VC) was proposed and applied for the patent by professor Liao Zhuan from Changhai Hospital, developed and manufactured by the Ankon Medical Technology Co., Ltd. The system consisted of a vibrating capsule and an external configuration device (ECD). It's 26.7 mm in length, 11.8 mm in diameter and 4.5 + 0.5 g in weight. Each VC has its own semiconductor chip with serial number in order to be recognized and controlled by ECD. VC can be stopped by ECD or mobile-phone application. There was a bidirectional radio frequency communication signal between VC and ECD. In addition, an application (APP) named VCP can be connected to ECD through smart phone to select mode and debug specific parameters for VC. The capsule can be activated by ECD, and then the vibration mode can be controlled by a configurator or an smartphone application.

Device: Sallowing VC during six weeks

Control group

PLACEBO COMPARATOR

The Intervention of control group were similar to VC group except the capsule function. Sham capsule we used in control group which had no function of vibrating.

Device: Sallowing VC during six weeks

Interventions

Sallowing VC during six weeks DEVICE

follow-up was required for at least 6 times, once every two weeks through the whole study. For patients who had no colonoscopy examination within a year, colonoscopy was a must to exclude organic diseases. These included blood routine, blood biochemistry, urine routine, fecal routine, fecal occult blood, thyroid stimulating hormone (TSH), blood pregnancy test and ECG examination. Patients should finish all the examination in the run-in period and at the end of treatment period. Dairy cards were designed mainly for the record of the daily defecation of patients and filled out by the enrolled patients, and the content included date, whether the patients swallow capsules (time), whether the patients discharge capsules (time), defecation, defecation time, degree of defecation exertion(0\~4), BSF scale, complete or incomplete defecation, whether the patient had the sense of anal obstruction, whether manual assistance was applied, and whether first-aid medicine was used (bisacodyl).

Also known as: Performing and reporting colonoscopy, Having laboratory examination, Filling diary cards, Evaluating the satisfaction

Control group; VC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged over 18 years and under 80 years;
• Patients who present with chronic constipation for more than 6 months and with SBM less than 3 times per week within recent 3 weeks and have at least one of the following symptoms for more than one-fourth (25%) during defecation:
• Straining;
• Lumpy or hard stools (bristol stool form (BSF scale 1\~2);
• Sensation of incomplete evacuation;
• Sensation of anorectal obstruction/blockage;
• Manual maneuvers to facilitate defecation. Note: The above criteria can only be applied during spontaneous defecation, including no taking of laxatives within 24 hours before defecation, etc.
• Organic diseases were not found by barium enema or colonoscopy in the past year.
• Insufficient criteria for irritable bowel syndrome.

You may not qualify if:

• Patients who have contraindications to gastroscopy or colonoscopy;
• Patients under 18 years or over 80 years;
• Active vomiting;
• Patients with a permanent pacemaker (e.g. implantable cardioverter-defibrillator);
• Patients with any electronic/magnetic/mechanically controlled devices (e.g. sacral nerve stimulators, bladder stimulators);
• Patients with dysphagia, odynophagia or known swallowing disorder;
• Patients with known Zenker's diverticulum;
• Patients with suspected bowel obstruction or bowel perforation;
• Patients with prior bowel obstruction;
• Patients with gastroparesis or known gastric outlet obstruction;
• Patients with known Crohn's disease;
• Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months;
• Patients who have received abdominopelvic radiotherapy treatment;
• Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure);
• Patients who are pregnant or lactating;

Sponsors & Collaborators

• Changhai Hospital: lead
• Changhai Hospital, Naval Medical University, Shanghai, China.: collaborator
• Beijing Xiehe Hospital, Beijing 100000, China.: collaborator
• Beijing Jishuitan Hospital, Beijing 100009, China.: collaborator
• Tianjin Medical University General Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Zhejiang Province Hospital of TCM, The First Affiliated Hospital of Zhejiang TCM University, Hangzhou, China.: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200437, China

Location

Related Publications (7)

• Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.

  PMID: 27144627 BACKGROUND

• Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91; quiz 1581, 1592. doi: 10.1038/ajg.2011.164. Epub 2011 May 24.

  PMID: 21606976 BACKGROUND

• Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.

  PMID: 25484196 BACKGROUND

• Nelson AD, Camilleri M, Acosta A, Boldingh A, Busciglio I, Burton D, Ryks M, Zinsmeister AR. A single-center, prospective, double-blind, sham-controlled, randomized study of the effect of a vibrating capsule on colonic transit in patients with chronic constipation. Neurogastroenterol Motil. 2017 Jul;29(7). doi: 10.1111/nmo.13034. Epub 2017 Feb 8.

  PMID: 28177172 BACKGROUND

• Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4.

  PMID: 28588191 BACKGROUND

• Nee J, Sugarman MA, Ballou S, Katon J, Rangan V, Singh P, Zubiago J, Kaptchuk TJ, Lembo A. Placebo Response in Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Dec;114(12):1838-1846. doi: 10.14309/ajg.0000000000000399.

  PMID: 31592782 BACKGROUND

• Zhu JH, Qian YY, Pan J, He C, Lan Y, Chen WN, Wang BM, Zhao W, Li JN, Li XQ, Lv B, Fan YH, Zuo XL, Li Z, Zou DW, Li ZS, Liao Z. Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial. EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May.

  PMID: 35518121 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Liao Zhuan, MD

  Department of Gastroenterology, Changhai Hospital, the Naval Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 17, 2020
• Study Start: November 14, 2018
• Primary Completion: May 11, 2020
• Study Completion: October 30, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)