ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001474145

Ethics application status

Approved

Date submitted

9/09/2019

Date registered

24/10/2019

Date last updated

6/04/2022

Date data sharing statement initially provided

24/10/2019

Date results provided

6/04/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Are probiotics useful post-tonsillectomy? – A randomised controlled study (feasibility trial)

Scientific title

Efficacy of probiotic gargles in reducing post-operative complications in adult post-tonsillectomy patients: A pilot triple-blinded, randomised controlled trial (feasibility trial)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1226-9224

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain post tonsillectomy

Secondary post tonsillectomy haemorrhage

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention group – Probiotic (Streptococcus salivarius K12, BLIS) gargles: 2 scoop (Concentration will be 125 million CFU/scoop) dissolved in 20ml of warm water, gargle for 30 seconds and then swallow, four times a day for 14 days
*1 Scoop equivalent to ¼ teaspoon

Participant diaries and bottle returns will be used to monitor adherence to the intervention

Participants will use the probiotic 24hrs after surgery

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control – Placebo (isomalt) gargles: 2 scoop dissolved in 20ml of warm water, gargle for 30 seconds and then swallow, four times a day for 14 days

*1 Scoop equivalent to ¼ teaspoon

The placebo isolmalt is identical in appearance to the probiotic

Control group

Placebo

Outcomes

Primary outcome [1]

Daily pain score determined by participant diary specifically designed for this study (Daily 14-day questionnaire)

Electronic questionnaire (specifically designed for this study) sent to patients via email or phone 14 days post surgery; Hard copy questionnaire (specifically designed for this study) if participants do not have access to email/mobile phone.

Timepoint [1]

14 days post surgery. Outpatient clinic follow up on days 5, 14 and 28.

Primary outcome [2]

Daily Requirement of endone as determined by participant diary specifically designed for study
Electronic questionnaire (specifically designed for this study) sent to patients via email or phone.
Hard copy questionnaire (specifically designed for this study) if participants do not have access to email/mobile phone.

Timepoint [2]

14 days post surgery
Outpatient clinic follow up on days 5, 14 and 28.

Primary outcome [3]

No pain as determined by participant diary specifically designed for study
Electronic questionnaire (specifically designed for this study)sent to patients via email or phone 14 days post surgery
Hard copy questionnaire (specifically designed for this study) if participants do not have access to email/mobile phone. .

Timepoint [3]

14 days post surgery
Outpatient clinic follow up on days 5, 14 and 28

Secondary outcome [1]

Readmission rate due to dehydration or poor oral intake as measured by hospital records

Timepoint [1]

We will look at the 28 days post tonsillectomy for each patient

Secondary outcome [2]

Amount of side effects daily experienced e.g. nausea, vomiting, constipation, drowsiness, halitosis, abdominal pain etc measured using participant diary specifically designed for study
Outcome tool: Daily questionnaire (specifically designed for this study)

Timepoint [2]

14 days post surgery
Outpatient clinic follow up on days 5, 14 and 28.

Secondary outcome [3]

Rate of post-tonsillectomy haemorrhage as assessed by hospital records
Outcome tool: 4-point Haemorrhage scale

Timepoint [3]

28 days post surgery

Secondary outcome [4]

Feasible Design of study – ability and time required of study staff to co-ordinate recruitment
The is a composite secondary outcome.
Outcome measurements include: 1) Ability to contact participants (Y/N) 2) duration of initial phone call to participants 3) staff required for initial recruitment phone call

Timepoint [4]

By completion of data collection

Secondary outcome [5]

Feasible Design of study - screening and clinic tasks will be assessed by recording number of staff required

Timepoint [5]

By completion of data collection

Secondary outcome [6]

Feasible Design of study - time required to recruit patients

Timepoint [6]

By completion of data collection

Secondary outcome [7]

Feasible recruitment and screening process will be assessed by time and number of people screened to enrol participants

Timepoint [7]

By completion of data collection

Secondary outcome [8]

Feasible randomisation process will be determined by ability to achieve balance of characteristics in group

Timepoint [8]

By completion of data collection

Secondary outcome [9]

Feasible Design of study - time required to screen and time required in clinic review.

Timepoint [9]

By completion of data collection

Secondary outcome [10]

Adherence – adherence in both groups assessed by taking probiotic/placebo gargle as measured by participant diaries and bottle return, attending follow up appointments and completing daily questionnaires (specifically designed for this study). All and each are a composite secondary outcome

Timepoint [10]

By completion of data collection

Secondary outcome [11]

- Safety will be assessed by the number and description of both serious adverse events (any admission to the emergency department or hospitalisation, life threatening events or results in significant morbidity or death) and other adverse events by group. Serious adverse events (including haemorrhage requiring operative intervention, readmission to pain and dehydration or septicaemia) will be adjudicated by a Independent Medical Monitoring team (two independent Ear Nose and Throat specialists) as not related to study, probably not related, unlikely but possibly related or probably related to study

Hospital records and participant diaries will be used to assess this outcome

Timepoint [11]

28 days post surgery

Secondary outcome [12]

Retention will be assessed number of participants that withdrew by group

Timepoint [12]

By completion of data collection

Eligibility

Key inclusion criteria

- Age 18-55
- Elective Tonsillectomy or adenotonsillectomy only
- Indication of operation (one of the following): asymmetric tonsillar enlargement, recurrent tonsillitis, previous quinsy (> one), sleep disordered breathing, halitosis, tonsillolith
- Weight must be more than 50kg.

Minimum age

18 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Allergic to opioids / codeine / Endone™ / paracetamol
Lactose intolerance
Unstable metabolic diseases/disorder
Heart failure or a history of endocarditis
Immunocompromised
Kidney disease
Liver disease
Hemorrhagic diathesis
Other concomitant surgical procedures.
Pregnancy
Patients who are currently taking NSAIDs e.g.: Celebrex™, Aspirin, etc.
Patients who are on regular opiates or Paracetamol
Recent use of probiotics within 1 month

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The trial or placebo pack will be provided on sealed envelope to the participant by pharmacist and will be recorded on an password protected electronic database.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomisation (using Microsoft Excel™) is undertaken by the department of pharmacy.
A pharmacist who will not be involved in the analysis of the trial results will prepare the randomisation schedule using block randomisation to maintain balance between treatment arms.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

As this trial is a feasibility pilot trial we have elected to choose a number of 30 patients (15 patients per group). This number was chosen as we are limited by number of patients currently on waiting list awaiting tonsillectomy or adenotonsillectomy. We have also elected this number to demonstrate as an ability to demonstrate safety and feasibility of the trial. Outcome measures such pain, use of analgesics, and rates of readmission will be calculated and a statistical analysis will be performed. We will use the results from this study to perform a more accurate power analysis in designing a larger clinical trial.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

23/09/2019

Date of last participant enrolment

Anticipated

Actual

15/12/2020

Date of last data collection

Anticipated

Actual

12/01/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Peninsula Health

Address [1]

Professor Srikanth Velandai
PO Box 52 Hastings Road, Frankston, VIC 3199

Country [1]

Australia

Primary sponsor type

Hospital

Name

Frankston Hospital

Address

Peninsula Health
2 Hastings Road, Frankston, VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics and Governance - Peninsula Health

Ethics committee address [1]

2 Hastings Road, Frankston VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2019

Approval date [1]

17/09/2019

Ethics approval number [1]

HREC/51745/PH-2019

Summary

Brief summary

Tonsillectomy is the most commonly performed otolaryngologic procedure. Despite advances in surgical techniques, the morbidity post-tonsillectomy remains high especially in the adult population. Pain remains the most consistent and incapacitating symptom experienced by patients post-operatively. This includes the need for analgesics as well as the inability to resume normal diet and activity for several days. Severe pain has been reported in 20% to 50% of children and young adults who have undergone tonsillectomy. There have been many studies investigating a variety of factors that influence post-tonsillectomy pain in the aim of reducing post-operative morbidity and requirement of rescue analgesics such as opiates, which can also have devastating effects. 
Hypothesis: For many years it has been suggested that post-tonsillectomy pain is further worsened by colonisation of tonsillar fossae with organisms that induce inflammatory response thereby making pain worse. 
Intervention: We aim to determine if using a probiotic gargle (Streptococcus salivarius) for 14 days post surgery reduces pain and reduces usage of rescue analgesics such as endone. Streptococcus salivarius is already established in the human oral cavity a few hours after birth and remains there as a predominant commensal inhabitant. This product comes in powder or lozenge form and is recommended for daily use. We aim to use the probiotic in powder form as a gargle to maximise contact with affected area (i.e. tonsillar fossa). The comparison group will use a placebo gargle (isomalt). A daily post-tonsillectomy diary will be sent daily via email or mobile phone to patients to complete. Patients who do not have access to email or mobile phone will be provided with hard copy of the questionnaire. If probiotics can reduce post-operative complications in adult tonsillectomy patient patients we would reduce morbidity, reduce requirement for opiate analgesia, prevent overuse of antibiotics and reduce substantial costs to the healthcare system.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David Hunter-Smith

Address

Peninsula Health
2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 0409787500

Fax

dhuntersmith@mac.com

Contact person for public queries

Name

Michael Nasserallah

Address

Peninsula Health
2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 0434431296

Fax

michael.nasserallah@gmail.com

Contact person for scientific queries

Name

Michael Nasserallah

Address

Peninsula Health
2 Hastings Road, Frankston VIC 3199

Country

Australia

Phone

+61 0434431296

Fax

michael.nasserallah@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3781	Informed consent form					376765-(Uploaded-25-09-2019-09-30-12)-Study-related document.pdf
5065	Ethical approval					376765-(Uploaded-25-09-2019-09-30-31)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Can probiotic gargles reduce post-tonsillectomy morbidity in adult patients? A pilot, triple-blind, randomised, controlled trial and feasibility study.	2023	https://dx.doi.org/10.1017/S0022215122000743

N.B. These documents automatically identified may not have been verified by the study sponsor.

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