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NCT Number: NCT05734859

Drinking Effect of Electrolyzed Alkaline Reduced Water on 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.

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Key information

Conditions

Chronic Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju College of Medicine

Wŏnju, Ganwon-do, 26426, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Electrolyzed Alkaline Ionizer

Device

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.

Other names: BTM-1200

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bristol stool scale score

    Time frame: 4 weeks treatment

    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.

  2. Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire

    Time frame: 4 weeks treatment

    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.

  3. Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire

    Time frame: 4 weeks treatment

    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.

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Official study title

A Pilot Study of Drinking Electrolyzed Hydrogen-rich Alkaline Reduced Water Generated by Alkaline Ionizer (BTM-1200) on the Chronic Functional Constipation

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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