Electric StimulationNCT06417424
Observe Intestinal Tract Cleaness of Senile Constipation Patients Used Gastrointestinal External Stimulation
A study testing gastrointestinal external stimulation in people with Electric Stimulation, run by Shanghai East Hospital at 1 site in China.
Trial summary
This is a prospective, randomized, double-blind controlled trial. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Electric Stimulation
- What is being tested?
- gastrointestinal external stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60-80 years old;
- Colonoscopy was planned;
- The diagnosis of constipation was in accordance with Rome Ⅳ criteria.
Who cannot join
- Acute myocardial infarction (within 6 months), severe heart failure (New York Heart Association class II-V, chronic renal failure (CKD stage II-V), or mental disorder;
- Colorectal resection;
- Drugs of aspirin, warfarin, or other anticoagulants, and coagulopathy;
- Oral administration any drugs that may affect gastrointestinal motility, such as proton pump inhibitors, non-steroidal anti-inflammatory drugs or antibiotics (within 4 weeks), probiotics (within 2 weeks);
- The following diseases：inflammatory bowel disease, frequent diarrhea, severe gastroparesis, intestinal perforation or obstruction;
- Participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai easthospital
Shanghai, Pudong New Area, 200120
Lan Zhong, MD, +86-13162099450, lanzhong@tongji.edu.cn
About this study
Official title: A Prospective, Randomized, Double-blind Controlled Clinical Study of Observation the Effect of Gastrointestinal External Stimulation on Intestinal Tract Cleaness in Patients With Senile Constipation
This is a prospective, randomized, double-blind controlled trial. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
Read the detailed description
The early detection of intestinal lesions is extremely important, and the quality of intestine cleanliness is an important factor for the quality of colonoscopy. The elderly are at high risk of intestinal diseases. However, surveys have found that the overall quality of bowel cleanliness in elderly patients undergoing colonoscopy is poor, which affects the detection rate of colon lesions. This is a prospective, randomized, double-blind, controlled clinical trial to observe whether combined gastrointestinal surface stimulation and transcutaneous electrical acupoint stimulation can improve the quality of bowel cleansing and increase the detection rate of intestinal diseases. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
- Conditions
- Electric Stimulation
- Being tested
- gastrointestinal external stimulation
- Keywords
- ntestine cleanliness, senile constipation patients, Gastrointestinal External Stimula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrointestinal external stimulationDevice
We used the device Gastrointestinal multifunctional therapeutic instrument. The positive pole was placed 1 to 2cm above the umbilicus, and the negative pole was placed 4 to 10 cm to the right of the midpoint between the xiphoid process and the umbilicus.
| Study group | Role | What they receive |
|---|---|---|
| experimental group 1 | Experimental | Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation for 3 days, and then oral administration of polyethylene glycol for intestinal cleansing. Receives: Device: gastrointestinal external stimulation |
| experimental group 2 | Experimental | Received gastrointestinal external stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. Receives: Device: gastrointestinal external stimulation |
| experimental group 3 | Experimental | Received transcutaneouselectrical acupoint stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. Receives: Device: gastrointestinal external stimulation |
| Control | No intervention | No stimulation was given. Oral administration of polyethylene glycol for intestinal cleansing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS)
Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
Measured: 1 year
The positive rate of intestinal diseases
The positive rate of intestinal diseases including polyps, adenoma, adenocarcinoma, enteritis, inflammatory bowel disease,diverticulum and so on by electronic colonoscopy.
Measured: 1 year
Secondary outcomes (4)
Adverse reactions
The adverse reactions included abdominal distension, pain, nausea, vomiting, and fatigue.
Measured: 1 year
Willingness to repeat
The Likert scale was used to judge willingness to repeat the same interventions of intestinal cleansing in future electronic colonoscopies.
Measured: 1 year
Gut microbiome alterations
Collected fresh fecal samples before and 3 days after electrical stimulation, high-throughput sequencing was used to detect intestinal microbiome , analyzed the changes .
Measured: 1 year
Gastrointestinal hormone
The serum levels of gastrointestinal hormones including substance P, motilin，ghrelin，growth hormone, neurotensin and vasoactive intestinal peptide were measured before and after intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Feb 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417424
- Sponsor's protocol ID
- DFSC-2023(CR)-077
- Status last verified
- May 2024
- First submitted
- 30 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind Controlled Clinical Study of Observation the Effect of Gastrointestinal External Stimulation on Intestinal Tract Cleaness in Patients With Senile Constipation
- ClinicalTrials.gov ID
- NCT06417424
- Acronym / sponsor ID
- DFSC-2023(CR)-077
- Conditions
- Electric Stimulation
- Keywords
- ntestine cleanliness, senile constipation patients, Gastrointestinal External Stimula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, double-blind controlled trial. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
Detailed description
The early detection of intestinal lesions is extremely important, and the quality of intestine cleanliness is an important factor for the quality of colonoscopy. The elderly are at high risk of intestinal diseases. However, surveys have found that the overall quality of bowel cleanliness in elderly patients undergoing colonoscopy is poor, which affects the detection rate of colon lesions. This is a prospective, randomized, double-blind, controlled clinical trial to observe whether combined gastrointestinal surface stimulation and transcutaneous electrical acupoint stimulation can improve the quality of bowel cleansing and increase the detection rate of intestinal diseases. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing.
| Arm | Type | Receives |
|---|---|---|
| experimental group 1 | Experimental | Device: gastrointestinal external stimulationReceived both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation for 3 days, and then oral administration of polyethylene glycol for intestinal cleansing. |
| experimental group 2 | Experimental | Device: gastrointestinal external stimulationReceived gastrointestinal external stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. |
| experimental group 3 | Experimental | Device: gastrointestinal external stimulationReceived transcutaneouselectrical acupoint stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing. |
| Control | No intervention | –No stimulation was given. Oral administration of polyethylene glycol for intestinal cleansing. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60-80 years old;
- Colonoscopy was planned;
- The diagnosis of constipation was in accordance with Rome Ⅳ criteria.
Key exclusion criteria (6 listed)
- Acute myocardial infarction (within 6 months), severe heart failure (New York Heart Association class II-V, chronic renal failure (CKD stage II-V), or mental disorder;
- Colorectal resection;
- Drugs of aspirin, warfarin, or other anticoagulants, and coagulopathy;
- Oral administration any drugs that may affect gastrointestinal motility, such as proton pump inhibitors, non-steroidal anti-inflammatory drugs or antibiotics (within 4 weeks), probiotics (within 2 weeks);
- The following diseases：inflammatory bowel disease, frequent diarrhea, severe gastroparesis, intestinal perforation or obstruction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastrointestinal external stimulationWe used the device Gastrointestinal multifunctional therapeutic instrument. The positive pole was placed 1 to 2cm above the umbilicus, and the negative pole was placed 4 to 10 cm to the right of the midpoint between the xiphoid process and the umbilicus. | Device | experimental group 1, experimental group 2, experimental group 3 |
Primary outcome
Boston Bowel Preparation Scale (BBPS)
Time frame: 1 year
Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.
The positive rate of intestinal diseases
Time frame: 1 year
The positive rate of intestinal diseases including polyps, adenoma, adenocarcinoma, enteritis, inflammatory bowel disease,diverticulum and so on by electronic colonoscopy.
4 secondary outcomes
Adverse reactions
Time frame: 1 year
Willingness to repeat
Time frame: 1 year
Gut microbiome alterations
Time frame: 1 year
Gastrointestinal hormone
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastrointestinal external stimulation in people with Electric Stimulation, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (BBPS) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.