Clinical trial NCT05528146: Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial
Official title: Effects of Psyllium on Constipation in Schizophrenic: A Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Constipation
Keywords: Schizophrenia
Psyllium
Constipation
Lead sponsor: Hungkuang University
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake.
Primary purpose: PREVENTION

Brief summary: Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.

Detailed description: The study was conducted in the psychiatric department of a hospital in the central region and utilized a crossover design involving a total of 42 patients with schizophrenia. The study employed a single-blind and simple randomization approach, with hospital wards divided into two groups. During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake. The research findings showed significant improvements in the frequency of constipation, stool consistency, and subjective experience of bowel movements in patients with schizophrenia following the intervention with psyllium husk.

Eligibility criteria: Inclusion Criteria:

1. DSM-V was diagnoses with schizophrenia inpatients.
2. Aged between 20 years and above.
3. Those who defecate less than 3 times a week, or those who have Bristol stool form scale between 1 and 2, or those who have constipation assessment scale (CAS) scores more than one point from questions 3 to 8; Or use PRN stool softeners (including oral and suppository) at least once a week.
4. Clear awareness and able to communicate in Chinese and Taiwanese.

Exclusion Criteria:

1. Patients with intestinal diseases such as colon cancer, irritable bowel syndrome and other organic intestinal diseases such as rectal bleeding, intestinal surgery, rectal prolapse and other medical history.
2. Cases with positive fecal occult blood test in the past six months, changes in stool thickness for one month, history of iron deficiency anemia, and unexplained weight loss for one month.
3. Those who are unable to cooperate due to obvious mental symptoms.
4. History of grain allergy, asthma.

Primary outcomes:
measure: frequency of constipation
timeFrame: 4weeks
Secondary outcomes:
measure: Stool type(bristol stool form)
timeFrame: 4weeks
Other outcomes:
measure: Constipation Assessment Scale, CAS
timeFrame: 4weeks
Locations:
city: Chang Hua
country: Taiwan
facility: Changhua Hospitol
state: Puxin Township
Study officials:
References: