Hemodialysis ComplicationNCT03527680
Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis
A study testing Lactobacillus rhamnosus in people with Hemodialysis Complication, run by nooshin dalili.
Trial summary
Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Lactobacillus rhamnosus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Dec 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptable performance of alimentary system
- Ability to drink at least 200 ml of water per day
- No history of being allergic to fungi and yeast
- Absence of acute medical illness
- life expectancy more than 3 months
- Accept and sign the consent
Who cannot join
- Patient's unwillingness to participate in the study
- History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
- Lactation or pregnancy
- Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.
About this study
Official title: Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial
Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.
Read the detailed description
Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).
- Conditions
- Hemodialysis Complication
- Being tested
- Lactobacillus rhamnosus, Placebo - Cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosusDietary supplement
daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus prepared by Tabriz Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris, after meal for 28 days
Placebo - CapDrug
Also called placebo
daily one capsule of placebo
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus rhamnosus | Experimental | received daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus Receives: Dietary Supplement: Lactobacillus rhamnosus |
| Placebo | Placebo comparator | received one placebo capsule per day Infant formula after meal for 28 days Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre- and post-treatment p-cresol levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Sep 2016
- Primary completion30 Nov 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- nooshin dalili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527680
- Sponsor's protocol ID
- IRCT20154182017N21
- Status last verified
- May 2018
- First submitted
- 21 May 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03527680
- Acronym / sponsor ID
- IRCT20154182017N21
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- nooshin daliliUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 17 May 2018 (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.
Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.
Detailed description
Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhamnosus | Experimental | Dietary Supplement: Lactobacillus rhamnosusreceived daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus |
| Placebo | Placebo comparator | Drug: Placebo - Capreceived one placebo capsule per day Infant formula after meal for 28 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acceptable performance of alimentary system
- Ability to drink at least 200 ml of water per day
- No history of being allergic to fungi and yeast
- Absence of acute medical illness
- life expectancy more than 3 months
Key exclusion criteria (4 listed)
- Patient's unwillingness to participate in the study
- History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
- Lactation or pregnancy
- Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.
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 rhamnosusdaily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus prepared by Tabriz Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris, after meal for 28 days | Dietary supplement | Lactobacillus rhamnosus |
| Placebo - CapAlso: placebodaily one capsule of placebo | Drug | Placebo |
Primary outcome
pre- and post-treatment p-cresol levels
Time frame: 4 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 17 May 2018.
- Individual participant dataSharing planned: Undecided
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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 Lactobacillus rhamnosus in people with Hemodialysis Complication, run by nooshin dalili.
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 4 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 17 May 2018. 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?
pre- and post-treatment p-cresol levels (time frame: 4 weeks). 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 17 May 2018.