Chronic ConstipationNCT05734859
Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
A study testing Electrolyzed Alkaline Ionizer in people with Chronic Constipation, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Electrolyzed Alkaline Ionizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2022to 13 Jan 2023
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 19 to 70 years old
- Those who meet the criteria for Roma Ⅳ function constipation
- Symptoms begin before 6 months and last for more than 3 months
- Those who do not have organic lesions that may cause constipation
- A patient who has personally signed the consent form
- If all the criteria meet
Who cannot join
- Those taking drugs such as opioid analgesics, antipsychotics, calcium blockers, and parasympathetic antagonists
- Kidney disease (renal failure, potassium excretion disorder, etc.)
- Patients with colon-related diseases (colon cancer, intestinal stenosis, rectal flow, anal fissure, rectal bleeding), diabetes, thyroid dysfunction, or anemia
- Pregnant or lactating women
- In addition to the above, those who are judged to be difficult to conduct research by the clinical trial director
- Excluded if at least one of the above criteria meet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation
The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks.
Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental device for 4 weeks.
Read the detailed description
Patients diagnosed with constipation will be recruited and screened according to the inclusion and exclusion criteria after sign in the informed consent form. The selected patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea) will be installed at each patient's house. The researcher will instruct patients drinking method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in 3-different times, and drink directly from the device on an empty stomach for 4 weeks. The clinical trial is conducted in a single group without a control group, and the efficacy is evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary outcome is the proportion of responders based on frequency of complete complete spontaneous bowel movement (CSBM).
- Conditions
- Chronic Constipation
- Being tested
- Electrolyzed Alkaline Ionizer
- Keywords
- constipation, hydrogen-rich alkaline ionized water, complete spontaneous bowel movement, patient assessment of constipation-symptoms, patient assessment of constipation-quality of life
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrolyzed Alkaline IonizerDevice
Also called BTM-1200
Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible.
| Study group | Role | What they receive |
|---|---|---|
| EHARW Treatment group | Experimental | The experimental group will drink a total amount of 20 mL/ kg body weight/day of EHARW for 4 weeks on an empty stomach according to the researcher's instruction. Receives: Device: Electrolyzed Alkaline Ionizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete spontaneous bowel movement (CSBM) frequency
CSBM is used to access the frequency of bowel movement. This indicates the efficacy of EHARW (pH 9.5) after 4-weeks of treatment in chronic constipation patients.
Measured: 4 weeks treatment
Secondary outcomes (3)
Bristol stool scale score
Fecal form is accessed by using Bristol stool scale. Fecal form indicate hardness of stool. Higher score present improvement of constipation symptoms. Similarly other questionnaires using self observation diary was also assessed including straining at defecation, stiffness of the stool, sensation of incomplete evacuation, and sensation of obstruction.
Measured: 4 weeks treatment
Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire
PAC-SYM is used to access constipation symptoms of patient before and after the intervention. This tool is categorized into 3 (abdominal, rectal, stool), and includes total 12 questions. Higher score present improvement of constipation symptoms.
Measured: 4 weeks treatment
Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire
PAC-QOL is used to access constipation-related quality of life before and after the intervention. This tool is categorized into 4: physical discomfort, psychological discomfort, worries and satisfaction, and consists of 28 questions. Higher score present improvement of constipation symptoms.
Measured: 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Nov 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- comparison between baseline and post-treatment in single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
- Investigators
- Kyu-Jae Lee, Ph.D., Principal investigator, Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734859
- Sponsor's protocol ID
- EMB-2022-03
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation
- ClinicalTrials.gov ID
- NCT05734859
- Acronym / sponsor ID
- EMB-2022-03
- Conditions
- Chronic Constipation
- Keywords
- constipation, hydrogen-rich alkaline ionized water, complete spontaneous bowel movement, patient assessment of constipation-symptoms, patient assessment of constipation-quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Feb 2023 (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.
The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks.
Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental device for 4 weeks.
Detailed description
Patients diagnosed with constipation will be recruited and screened according to the inclusion and exclusion criteria after sign in the informed consent form. The selected patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea) will be installed at each patient's house. The researcher will instruct patients drinking method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in 3-different times, and drink directly from the device on an empty stomach for 4 weeks. The clinical trial is conducted in a single group without a control group, and the efficacy is evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary outcome is the proportion of responders based on frequency of complete complete spontaneous bowel movement (CSBM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- comparison between baseline and post-treatment in single group
| Arm | Type | Receives |
|---|---|---|
| EHARW Treatment group | Experimental | Device: Electrolyzed Alkaline IonizerThe experimental group will drink a total amount of 20 mL/ kg body weight/day of EHARW for 4 weeks on an empty stomach according to the researcher's instruction. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 19 to 70 years old
- Those who meet the criteria for Roma Ⅳ function constipation
- Symptoms begin before 6 months and last for more than 3 months
- Those who do not have organic lesions that may cause constipation
- A patient who has personally signed the consent form
Key exclusion criteria (6 listed)
- Those taking drugs such as opioid analgesics, antipsychotics, calcium blockers, and parasympathetic antagonists
- Kidney disease (renal failure, potassium excretion disorder, etc.)
- Patients with colon-related diseases (colon cancer, intestinal stenosis, rectal flow, anal fissure, rectal bleeding), diabetes, thyroid dysfunction, or anemia
- Pregnant or lactating women
- In addition to the above, those who are judged to be difficult to conduct research by the clinical trial director
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 |
|---|---|---|
| Electrolyzed Alkaline IonizerAlso: BTM-1200Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible. | Device | EHARW Treatment group |
Primary outcome
Complete spontaneous bowel movement (CSBM) frequency
Time frame: 4 weeks treatment
CSBM is used to access the frequency of bowel movement. This indicates the efficacy of EHARW (pH 9.5) after 4-weeks of treatment in chronic constipation patients.
3 secondary outcomes
Bristol stool scale score
Time frame: 4 weeks treatment
Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire
Time frame: 4 weeks treatment
Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire
Time frame: 4 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Kyu-Jae Lee, Ph.D. principal investigator
Department of Convergence Medicine, Wonju College of Medicine, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolyzed Alkaline Ionizer in people with Chronic Constipation, run by Wonju Severance Christian Hospital at 1 site in South Korea.
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 6 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: finished, as of the sponsor's last update on 3 Apr 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete spontaneous bowel movement (CSBM) frequency (time frame: 4 weeks treatment). 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 3 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.