Necrosis of Femoral HeadNCT04017403
Probiotics Attenuate Postoperative Cognition Decline
A study testing Bifidobacterium triple live capsule in people with Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 3 sites in China.
Trial summary
The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur
- What is being tested?
- Bifidobacterium triple live capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesChina
- Study dates
- 15 Dec 2019to 31 Dec 2023
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- . Age is greater than or equal to 65 years old
- . Can communicate normally
- . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
- . ASA graded at I-II level
- . Patient or family informed consent
Who cannot join
- . Have a brain disease, or have a history of brain disease
- .MMSE check of less than 24 points.
- . History of neurological and psychological disorders including AD, stroke, psychosis
- . Serious hearing or visual impairment
- . Preoperative systolic blood pressure >190mmhg, or diastolic blood pressure >100mmhg
- . The patient or family refuses
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Jin Cheng people's hospital
Jincheng, Shanxi
Jinping Wang
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
diansan su, Dr., +862168383702, diansansu@yahoo.com
- Recruiting
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality
Xiaoxue Hu, ykxiaoxue@126.com
About this study
Official title: Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients
The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.
- Conditions
- Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur, Lumbar Disc Herniation
- Being tested
- Bifidobacterium triple live capsule, Placebos
- Keywords
- postoperative cognitive dysfunction, postopeartive delirium, Probiotics
- Medical subject headings
- Osteoarthritis, Knee, Femoral Neck Fractures, Intervertebral Disc Displacement, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium triple live capsuleDrug
Also called Peifei Kang Capsule
Bifidobacterium triple live capsules, indications for acute and chronic diarrhea and constipation caused by intestinal flora imbalance, can also be used for the treatment of mild to moderate acute diarrhea, chronic diarrhea and indigestion, bloating, and adjuvant treatment of intestinal flora Endotoxemia caused by disorders.
PlacebosDrug
Also called Placebo
Placebos were administrated as same as the bifidobacterium live capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | The probiotic group was treated with Bifidobacterium tripleis,one day before surgery to the sixth day after surgerythe drug is taken orally, 4 capsules at a time, 2 times a day. Receives: Drug: Bifidobacterium triple live capsule |
| Placebo group | Placebo comparator | The control group was given the same package of placebo,one day before surgery to the sixth day after surgery. The drug is taken orally, 4 capsules at a time, 2 times a day. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POCD 7days after surgery
Measured: The seventh day after surgery
Secondary outcomes (2)
Incidence of POCD 1 month after operation
Measured: One month after surgery
Incidence of POD 7 days after surgery
Use the CAM scale to assess whether a patient has postoperative delirium
Measured: One day after surgery to the seventh day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start15 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrosis of Femoral HeadStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- su diansan, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017403
- Sponsor's protocol ID
- PAPOCD
- Status last verified
- Apr 2022
- First submitted
- 9 Jul 2019
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Chen Y, Tang Y, Zhang Y, Zhang X, Su D. Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial. Trials. 2023 Feb 25;24(1):146. doi: 10.1186/s13063-023-07167-6.
PubMed 36841790
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients
- ClinicalTrials.gov ID
- NCT04017403
- Acronym / sponsor ID
- PAPOCD
- Conditions
- Necrosis of Femoral Head, Knee Osteoarthritis, Fracture of Neck of Femur, Lumbar Disc Herniation
- Keywords
- postoperative cognitive dysfunction, postopeartive delirium, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Jul 2019 (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.
The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Drug: Bifidobacterium triple live capsuleThe probiotic group was treated with Bifidobacterium tripleis,one day before surgery to the sixth day after surgerythe drug is taken orally, 4 capsules at a time, 2 times a day. |
| Placebo group | Placebo comparator | Drug: PlacebosThe control group was given the same package of placebo,one day before surgery to the sixth day after surgery. The drug is taken orally, 4 capsules at a time, 2 times a day. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- . Age is greater than or equal to 65 years old
- . Can communicate normally
- . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
- . ASA graded at I-II level
- . Patient or family informed consent
Key exclusion criteria (6 listed)
- . Have a brain disease, or have a history of brain disease
- .MMSE check of less than 24 points.
- . History of neurological and psychological disorders including AD, stroke, psychosis
- . Serious hearing or visual impairment
- . Preoperative systolic blood pressure >190mmhg, or diastolic blood pressure >100mmhg
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 |
|---|---|---|
| Bifidobacterium triple live capsuleAlso: Peifei Kang CapsuleBifidobacterium triple live capsules, indications for acute and chronic diarrhea and constipation caused by intestinal flora imbalance, can also be used for the treatment of mild to moderate acute diarrhea, chronic diarrhea and indigestion, bloating, and adjuvant treatment of intestinal flora Endotoxemia caused by disorders. | Drug | Probiotic group |
| PlacebosAlso: PlaceboPlacebos were administrated as same as the bifidobacterium live capsule | Drug | Placebo group |
Primary outcome
Incidence of POCD 7days after surgery
Time frame: The seventh day after surgery
2 secondary outcomes
Incidence of POCD 1 month after operation
Time frame: One month after surgery
Incidence of POD 7 days after surgery
Time frame: One day after surgery to the seventh day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 36841790Zhang X, Chen Y, Tang Y, Zhang Y, Zhang X, Su D. Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial. Trials. 2023 Feb 25;24(1):146. doi: 10.1186/s13063-023-07167-6.
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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.
su diansan study chair
RenJi Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium triple live capsule in people with Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 3 sites in China.
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 5 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 tang ying, Bachelor (13918859887 ext. 18616514088, 421941497@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POCD 7days after surgery (time frame: The seventh day 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 NCT04017403, which also lists 1 linked publication.
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 2 May 2022.