Irritable Bowel Syndrome With Subthreshold DepressionNCT05266443
Lactobacillus-containing Cultured Milk Drink Alleviates Depression Score Among Adults With Irritable Bowel Syndrome
A study testing Lactobacillus containing cultured milk drink in people with Irritable Bowel Syndrome With Subthreshold Depression, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Irritable bowel syndrome (IBS) is frequently associated with any form of psychiatric comorbidities including subthreshold or subclinical depression. Modification of gut ecology with probiotics has implicitly improved IBS and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Subthreshold Depression
- What is being tested?
- Lactobacillus containing cultured milk drink
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Nov 2019to 31 Jul 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years old,
- Meet ROME IV criteria for irritable bowel syndrome,
- Consented to participate in the study.
Who cannot join
- Lactose intolerance,
- Gastrointestinal disorders such as inflammatory bowel diseases, liver diseases, pancreatic diseases or malignancies,
- Any neurological diseases or malignancies,
- Pregnant and lactating mothers,
- Any metabolic diseases such as hypertension, hypercholesterolaemia, diabetes mellitus, hyper- and hypothyroidism.
- Known psychiatric diagnoses or/and consume psychotropic drugs,
- Ongoing electroconvulsive therapy (ECT),
- Consumption of antibiotics, probiotics, prebiotics, symbiotics products, laxatives, antispasmodics, and/or anticholinergics who refuse to consent for participation.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, 56000
Prof. Dr. Norfilza Mohd Mokhtar, +60391458424, norfilza@ppukm.ukm.edu.my
Prof. Dr. Raja Affendi Raja Ali, +60391455022, draffendi@ppukm.ukm.edu.my
About this study
Official title: The Efficacy of Lactobacillus-containing Cultured Milk Drink in Alleviating Subthreshold Depression Among Adults With Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is frequently associated with any form of psychiatric comorbidities including subthreshold or subclinical depression. Modification of gut ecology with probiotics has implicitly improved IBS and depressive symptoms. However, the efficacy of probiotics on IBS with existing subthreshold depression remain elusive. Therefore, the aim of this study is to evaluate the effects of lactobacillus-containing cultured milk drink on depression scores in adults diagnosed with IBS.
Read the detailed description
A total of 140 subjects who fulfilled Rome IV criteria for IBS will be recruited from a tertiary medical centre and among public volunteers. The depression status and categories will be assessed using the Centre Epidemiologic Studies Depression Scale Revised questionnaire (CESD-R): normal mood (score<16), or subthreshold depression (score>16). The subjects are randomised and blinded into four groups: Group A (Normal mood with placebo, n=35), Group B (Normal mood with probiotics, n=35), Group C (Subthreshold depression with placebo, n=35) and Group D (Subthreshold depression with probiotics, n=35). The subjects will be instructed to consume two bottles of cultured milk drink daily for 12 weeks. The probiotic cultured milk drinks contained 10^9 cfu L. CASEI-01 and LA-5. The severity of depression will be measured using Patient Health Questionnaire (PHQ-9) at pre- and post-12-week intervention. Secondary outcome on IBS symptoms severity will be assessed with IBS Symptoms Severity Score (IBS-SSS) and IBS Quality of Life (IBS-QOL).
- Being tested
- Lactobacillus containing cultured milk drink, Placebo cultured milk drink
- Keywords
- irritable bowel syndrome, subthreshold depression, probiotics, IBS, subclinical depression
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus containing cultured milk drinkDietary supplement
Each bottle of 125ml cultured milk drink contains a billion colony forming unit (CFU) Lactobacillus acidophillus (LA-5) and Lactobacillus paracasei (L. CASEI-01). Each patient will be given 2 bottles to consume daily for a period of 12 weeks.
Placebo cultured milk drinkDietary supplement
The placebo prepared was identical to the probiotic-containing product in terms of color, taste and packaging. However, there is no trace of live microorganism in this product.
| Study group | Role | What they receive |
|---|---|---|
| Irritable bowel syndrome with normal mood receiving placebo | Placebo comparator | A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be supplemented with placebo drinks. Receives: Dietary Supplement: Placebo cultured milk drink |
| Irritable bowel syndrome with normal mood receiving probiotics | Active comparator | A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be given lactobacillus-containing cultured milk drinks. Receives: Dietary Supplement: Lactobacillus containing cultured milk drink |
| Irritable bowel syndrome with subthreshold depression receiving placebo | Placebo comparator | A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be supplemented with placebo drinks. Receives: Dietary Supplement: Placebo cultured milk drink |
| Irritable bowel syndrome with subthreshold depression receiving probiotics | Experimental | A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be given lactobacillus-containing cultured milk drinks. Receives: Dietary Supplement: Lactobacillus containing cultured milk drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression score
The Centre for Epidemiologic Studies Depression Scale Revised Version (CESD-R) will be used to classify the patients according to their depression status.
Measured: 12 weeks
Depression severity scale
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity scale for the patients.
Measured: 12 weeks
Secondary outcomes (4)
Quality of life score
The life quality of patients will be measured using the Irritable bowel syndrome Quality of Life Questionnaire (IBS-QOL).
Measured: 12 weeks
IBS severity score
Any changes in gastrointestinal symptoms severity related to IBS will be quantify using the Irritable bowel syndrome Severity Scoring System (IBS-SSS).
Measured: 12 weeks
Acute stress biomarker
Morning blood sample will be collected to measure serum cortisol level among patients with IBS.
Measured: 12 weeks
Depression biomarker
Blood samples collected will be analysed to measure the serum serotonin level of patients with IBS.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start22 Nov 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With Subthreshold DepressionStudies 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
- This is a randomized and parallel study involving patients with IBS who attended gastroenterology clinics at Universiti Kebangsaan Malaysia Medical Center (UKMMC). The recruited subjects will be categorized according to their CESD-R scores and randomly allocated into receiving either placebo or probiotic-containing cultured milk drink for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Cotra Enterprises Sdn. Bhd.
- Responsible party
- Principal investigator, PROF DR RAJA AFFENDI RAJA ALI, National University of Malaysia
- Investigators
- Prof. Dr. Raja Affendi Raja Ali, Principal investigator, Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266443
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2019-312
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lactobacillus-containing Cultured Milk Drink in Alleviating Subthreshold Depression Among Adults With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05266443
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2019-312
- Keywords
- irritable bowel syndrome, subthreshold depression, probiotics, IBS, subclinical depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Cotra Enterprises Sdn. Bhd.
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 4 Mar 2022 (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.
Irritable bowel syndrome (IBS) is frequently associated with any form of psychiatric comorbidities including subthreshold or subclinical depression. Modification of gut ecology with probiotics has implicitly improved IBS and depressive symptoms. However, the efficacy of probiotics on IBS with existing subthreshold depression remain elusive. Therefore, the aim of this study is to evaluate the effects of lactobacillus-containing cultured milk drink on depression scores in adults diagnosed with IBS.
Detailed description
A total of 140 subjects who fulfilled Rome IV criteria for IBS will be recruited from a tertiary medical centre and among public volunteers. The depression status and categories will be assessed using the Centre Epidemiologic Studies Depression Scale Revised questionnaire (CESD-R): normal mood (score<16), or subthreshold depression (score>16). The subjects are randomised and blinded into four groups: Group A (Normal mood with placebo, n=35), Group B (Normal mood with probiotics, n=35), Group C (Subthreshold depression with placebo, n=35) and Group D (Subthreshold depression with probiotics, n=35). The subjects will be instructed to consume two bottles of cultured milk drink daily for 12 weeks. The probiotic cultured milk drinks contained 10^9 cfu L. CASEI-01 and LA-5. The severity of depression will be measured using Patient Health Questionnaire (PHQ-9) at pre- and post-12-week intervention. Secondary outcome on IBS symptoms severity will be assessed with IBS Symptoms Severity Score (IBS-SSS) and IBS Quality of Life (IBS-QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a randomized and parallel study involving patients with IBS who attended gastroenterology clinics at Universiti Kebangsaan Malaysia Medical Center (UKMMC). The recruited subjects will be categorized according to their CESD-R scores and randomly allocated into receiving either placebo or probiotic-containing cultured milk drink for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Irritable bowel syndrome with normal mood receiving placebo | Placebo comparator | Dietary Supplement: Placebo cultured milk drinkA total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be supplemented with placebo drinks. |
| Irritable bowel syndrome with normal mood receiving probiotics | Active comparator | Dietary Supplement: Lactobacillus containing cultured milk drinkA total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be given lactobacillus-containing cultured milk drinks. |
| Irritable bowel syndrome with subthreshold depression receiving placebo | Placebo comparator | Dietary Supplement: Placebo cultured milk drinkA total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be supplemented with placebo drinks. |
| Irritable bowel syndrome with subthreshold depression receiving probiotics | Experimental | Dietary Supplement: Lactobacillus containing cultured milk drinkA total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be given lactobacillus-containing cultured milk drinks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years old,
- Meet ROME IV criteria for irritable bowel syndrome,
- Consented to participate in the study.
Key exclusion criteria (8 listed)
- Lactose intolerance,
- Gastrointestinal disorders such as inflammatory bowel diseases, liver diseases, pancreatic diseases or malignancies,
- Any neurological diseases or malignancies,
- Pregnant and lactating mothers,
- Any metabolic diseases such as hypertension, hypercholesterolaemia, diabetes mellitus, hyper- and hypothyroidism.
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 |
|---|---|---|
| Lactobacillus containing cultured milk drinkEach bottle of 125ml cultured milk drink contains a billion colony forming unit (CFU) Lactobacillus acidophillus (LA-5) and Lactobacillus paracasei (L. CASEI-01). Each patient will be given 2 bottles to consume daily for a period of 12 weeks. | Dietary supplement | Irritable bowel syndrome with normal mood receiving probiotics, Irritable bowel syndrome with subthreshold depression receiving probiotics |
| Placebo cultured milk drinkThe placebo prepared was identical to the probiotic-containing product in terms of color, taste and packaging. However, there is no trace of live microorganism in this product. | Dietary supplement | Irritable bowel syndrome with normal mood receiving placebo, Irritable bowel syndrome with subthreshold depression receiving placebo |
Primary outcome
Depression score
Time frame: 12 weeks
The Centre for Epidemiologic Studies Depression Scale Revised Version (CESD-R) will be used to classify the patients according to their depression status.
Depression severity scale
Time frame: 12 weeks
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity scale for the patients.
4 secondary outcomes
Quality of life score
Time frame: 12 weeks
IBS severity score
Time frame: 12 weeks
Acute stress biomarker
Time frame: 12 weeks
Depression biomarker
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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.
Prof. Dr. Raja Affendi Raja Ali principal investigator
Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus containing cultured milk drink in people with Irritable Bowel Syndrome With Subthreshold Depression, run by National University of Malaysia at 1 site in Malaysia.
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 8 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 4 Mar 2022. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Contact Prof. Dr. Norfilza Mohd Mokhtar (+60391458424, norfilza@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression score (time frame: 12 weeks). 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 4 Mar 2022.