Functional ConstipationNCT04620317
Effects of Synbiotics on FC and Other Contributing Factors
A study testing Synbiotic in people with Functional Constipation, run by Universiti Putra Malaysia.
Trial summary
Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2018
- 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
- Malaysian of either gender;
- 18 to 65 years old;
- Body mass index (BMI) 16.0 to 29.9 kg/m2;
- Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist
Who cannot join
- Vulnerable groups of pregnant and breastfeeding women;
- Physically or mentally handicapped individuals;
- Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
- Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
- Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.
- To avoid the likelihood of co-intervention bias, the following respondents were excluded:
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- On gastrointestinal medications;
- Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period;
- Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.
About this study
Official title: Effects of Synbiotics on Functional Constipation and Other Contributing Factors Among Constipated Individuals in Serdang, Selangor, Malaysia
Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p < 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.
Read the detailed description
Digestive system disease is the top ten principal causes of morbidity and mortality among Malaysians whereby functional constipation (FC) is the commonest functional gastrointestinal disorders (FGIDs) reported. Although numerous treatments are available, but over-the-counter drugs which have low product safety and possible toxicity were always given as the treatment option. Synbiotic have been well-studied to improve digestive health includes constipation. Thus, the objectives of this study were to determine the prevalence of FC and to evaluate the effects of synbiotic supplement on improving FC symptoms and contributing factors among constipated individuals in Serdang, Selangor. This study comprised of two parts which were screening and intervention part. The prevalence of functional constipation was relatively high in the study community. Synbiotic supplement was effective in the improvement of functional constipation symptoms, quality of life, and psychological factors. However, the positive improvement in placebo group indicated the existence of placebo effects which led to the improvement in quality of life and changes in psychological factors. Therefore, the current findings are useful information for future intervention in improving functional constipation symptoms.
- Conditions
- Functional Constipation
- Being tested
- Synbiotic, Placebo
- Keywords
- Prevalence, functional constipation, Rome III criteria, Bristol Stool Form Scale, defecation frequency, PAC-SYM, PAC-QOL, randomised controlled trial (RCT), synbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose
PlaceboDietary supplement
Non-active ingredients - Maltodextrins
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Active comparator | The product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet. Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | Placebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation frequency
Defecation frequency was measured through participants' self reported defecation frequency in a week.
Measured: 16 weeks
Stool types - Bristol Stool Form (BSF) Scale
BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.
Measured: 16 weeks
Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)
PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.
Measured: 16 weeks
Secondary outcomes (2)
Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)
Quality of life was measured using Patients Assessment of Constipation Quality of Life (PAC-QOL). PAC-QOL consists of a total of 28 questions which was grouped into four domains include physical discomfort, psychological discomfort, worries and concerns, and satisfaction. It comprised with a 5-point Likert scale ranging from 0 (Not at all/None of the time) to 4 (Extremel/All of the time).The values of subscales and total scores for PAC-QOL scores were then computed as average item response within the scales and for the global score. Lower score point indicates a better quality of life of the respective participant.
Measured: 16 weeks
Psychological factor - Depression, Anxiety, and Stress scale (DASS)
Psychological factor was measured using Depression, Anxiety, and Stress scale (DASS). DASS was used to self-report the severity of depression, anxiety and stress level. The questionnaire based on 4-point Likert scale, ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much, or most of the time). The scores of depression, anxiety, and stress were summated for the relevant items followed by categorised to the severity of the condition. Lower score point indicates a less severity of the respective participant.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study startJan 2015
- Primary completionApr 2016
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Rosita Jamaluddin, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620317
- Sponsor's protocol ID
- SynFC_001
- Status last verified
- Nov 2020
- First submitted
- 16 Oct 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Synbiotics on Functional Constipation and Other Contributing Factors Among Constipated Individuals in Serdang, Selangor, Malaysia
- ClinicalTrials.gov ID
- NCT04620317
- Acronym / sponsor ID
- SynFC_001
- Conditions
- Functional Constipation
- Keywords
- Prevalence, functional constipation, Rome III criteria, Bristol Stool Form Scale, defecation frequency, PAC-SYM, PAC-QOL, randomised controlled trial (RCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Nov 2020 (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.
Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p < 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.
Detailed description
Digestive system disease is the top ten principal causes of morbidity and mortality among Malaysians whereby functional constipation (FC) is the commonest functional gastrointestinal disorders (FGIDs) reported. Although numerous treatments are available, but over-the-counter drugs which have low product safety and possible toxicity were always given as the treatment option. Synbiotic have been well-studied to improve digestive health includes constipation. Thus, the objectives of this study were to determine the prevalence of FC and to evaluate the effects of synbiotic supplement on improving FC symptoms and contributing factors among constipated individuals in Serdang, Selangor. This study comprised of two parts which were screening and intervention part. The prevalence of functional constipation was relatively high in the study community. Synbiotic supplement was effective in the improvement of functional constipation symptoms, quality of life, and psychological factors. However, the positive improvement in placebo group indicated the existence of placebo effects which led to the improvement in quality of life and changes in psychological factors. Therefore, the current findings are useful information for future intervention in improving functional constipation symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Active comparator | Dietary Supplement: SynbioticThe product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Malaysian of either gender;
- 18 to 65 years old;
- Body mass index (BMI) 16.0 to 29.9 kg/m2;
- Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist
Key exclusion criteria (9 listed)
- Vulnerable groups of pregnant and breastfeeding women;
- Physically or mentally handicapped individuals;
- Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
- Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
- Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.
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 |
|---|---|---|
| Synbiotic10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose | Dietary supplement | Synbiotic |
| PlaceboNon-active ingredients - Maltodextrins | Dietary supplement | Placebo |
Primary outcome
Defecation frequency
Time frame: 16 weeks
Defecation frequency was measured through participants' self reported defecation frequency in a week.
Stool types - Bristol Stool Form (BSF) Scale
Time frame: 16 weeks
BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.
Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)
Time frame: 16 weeks
PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.
2 secondary outcomes
Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)
Time frame: 16 weeks
Psychological factor - Depression, Anxiety, and Stress scale (DASS)
Time frame: 16 weeks
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 6 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Functional Constipation, run by Universiti Putra 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 4 inclusion and 9 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Defecation frequency (time frame: 16 weeks). The study lists 3 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 6 Nov 2020.