Gastric Bypass SurgeryPhase 2/3NCT02708589
The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery
A Phase 2/3 study testing probiotic in people with Gastric Bypass Surgery, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Gastric Bypass Surgery
- What is being tested?
- probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Sep 2015to Sep 2017
- Phase
- Phase 2/3
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI> 40 or >35 plus other morbidities
- Undergoing the gastric bypass surgery
- Willing to participate in the study
Who cannot join
- History of any chronic GI or kidney disorders, malignancies, or immune deficiencies
- Taking any immunomodulatory or immunosuppressor medications
- Taking Antibiotics from 4 weeks before and during the intervention
- Being on special diet such as vegetarian diet
- Doing as a professional Athlete
- Pregnancy and Lactation
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
NNFTRI clinic
Tehran, Tehran Province, 19435
Azita Hekmatdoost, MD, PhD, 9123065084, a_hekmat2000@yahoo.com
About this study
Official title: The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.
- Conditions
- Gastric Bypass Surgery
- Being tested
- probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Active comparator | the probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, and Lactobacillus bulgaricus) and prebiotic (fructooligosaccharide). Receives: Dietary Supplement: probiotic |
| Placebo | Placebo comparator | Placebo capsules have identical appearance to probiotic capsules and contain Maltodextrin. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weigh of the participants will be measured in Kg.
Measured: 3 months after surgery
Secondary outcomes (4)
serum level of vitamin B12 (mg/dl)
Measured: 3 months after surgery
serum level of vitamin B12 (mg/dl)
Measured: 12 months after surgery
serum level of vitamin D(ng/ml)
Measured: 3 months after surgery
serum level of vitamin D (ng/ml)
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Bypass SurgeryStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708589
- Sponsor's protocol ID
- 600
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
Publications
Mokhtari Z, Karbaschian Z, Pazouki A, Kabir A, Hedayati M, Mirmiran P, Hekmatdoost A. The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13 Months Follow-Up. Obes Surg. 2019 Apr;29(4):1248-1258. doi: 10.1007/s11695-018-03667-6.
PubMed 30612325Karbaschian Z, Mokhtari Z, Pazouki A, Kabir A, Hedayati M, Moghadam SS, Mirmiran P, Hekmatdoost A. Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Obes Surg. 2018 Sep;28(9):2874-2885. doi: 10.1007/s11695-018-3280-2.
PubMed 29725975
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT02708589
- Acronym / sponsor ID
- 600
- Conditions
- Gastric Bypass Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- 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.
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Active comparator | Dietary Supplement: probioticthe probiotics capsules contain 7 strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, and Lactobacillus bulgaricus) and prebiotic (fructooligosaccharide). |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules have identical appearance to probiotic capsules and contain Maltodextrin. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- BMI> 40 or >35 plus other morbidities
- Undergoing the gastric bypass surgery
- Willing to participate in the study
Key exclusion criteria (6 listed)
- History of any chronic GI or kidney disorders, malignancies, or immune deficiencies
- Taking any immunomodulatory or immunosuppressor medications
- Taking Antibiotics from 4 weeks before and during the intervention
- Being on special diet such as vegetarian diet
- Doing as a professional Athlete
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 |
|---|---|---|
| probiotic | Dietary supplement | probiotic |
| Placebo | Other | Placebo |
Primary outcome
weigh of the participants will be measured in Kg.
Time frame: 3 months after surgery
4 secondary outcomes
serum level of vitamin B12 (mg/dl)
Time frame: 3 months after surgery
serum level of vitamin B12 (mg/dl)
Time frame: 12 months after surgery
serum level of vitamin D(ng/ml)
Time frame: 3 months after surgery
serum level of vitamin D (ng/ml)
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Derived from this study: PubMed 30612325Mokhtari Z, Karbaschian Z, Pazouki A, Kabir A, Hedayati M, Mirmiran P, Hekmatdoost A. The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13 Months Follow-Up. Obes Surg. 2019 Apr;29(4):1248-1258. doi: 10.1007/s11695-018-03667-6.
- Derived from this study: PubMed 29725975Karbaschian Z, Mokhtari Z, Pazouki A, Kabir A, Hedayati M, Moghadam SS, Mirmiran P, Hekmatdoost A. Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Obes Surg. 2018 Sep;28(9):2874-2885. doi: 10.1007/s11695-018-3280-2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing probiotic in people with Gastric Bypass Surgery, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 6 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 15 Mar 2016. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weigh of the participants will be measured in Kg. (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708589, which also lists 2 linked publications.
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 15 Mar 2016.