A Phase 2 interventional study of Curcumin extract and Ciprofloxacin in Typhoid Carrier, Typhoid Fever and Salmonella Typhi Infection, sponsored by Universitas Sebelas Maret. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Universitas Sebelas Maret · Phase 2, Interventional, and Treatment
Some people keep carrying Salmonella Typhi after they recover from typhoid fever. These carriers have no symptoms. They can still pass the bacteria into food. Food handlers in the Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) cook for many school children every day. One carrier in an MBG kitchen can cause an outbreak.
Standard antibiotics often fail to clear the carrier state. The bacteria form a biofilm on gallstones. This biofilm protects them from antibiotics. Curcumin is the main active compound of turmeric. In laboratory studies, curcumin weakens the biofilm. It may also help ciprofloxacin stay longer inside the bacteria.
This study has two stages. In stage 1, the study team screens 100 MBG food handlers in Surakarta, Indonesia. Each person gives a blood sample for the Widal test. People with a high Widal titer give a rectal swab for culture. In stage 2, people with a positive Salmonella Typhi culture are randomly assigned to one of two groups. One group takes ciprofloxacin plus curcumin extract. The other group takes ciprofloxacin plus placebo. Treatment lasts 28 days.
The main question is whether curcumin added to ciprofloxacin clears Salmonella Typhi better than ciprofloxacin alone. The main outcome is a negative rectal swab culture 30 days after treatment ends.
Background
Indonesia has a high burden of typhoid fever. A chronic carrier is a healthy person who keeps shedding Salmonella Typhi in the stool after the illness. The gallbladder is the main site of carriage. Gallstones raise the risk of long-term carriage. Carriers do not feel sick. Because of this, they are rarely found and rarely treated.
The Free Nutritious Meal Program (Makan Bergizi Gratis, MBG) is a national program. Each MBG kitchen serves meals to many schools. A food handler who is a carrier can spread the bacteria to many children at once. Finding and treating carriers among food handlers can protect food safety at the source.
Fluoroquinolones such as ciprofloxacin are used to treat carriers. Treatment often fails. Salmonella Typhi forms a biofilm on gallstones. The biofilm is made of sugars, proteins, and DNA. It blocks the entry of antibiotics. Curcumin from Curcuma longa has shown anti-biofilm effects in laboratory studies. It lowers the genes that control biofilm matrix production. It may also block bacterial efflux pumps. This may keep more ciprofloxacin inside the bacteria. Most of this evidence comes from in vitro and animal studies. This study tests the idea in people.
Objectives
Study design
This is a two-stage study done in Surakarta, Central Java, Indonesia. The study runs for about 24 months. Recruitment is done with the Surakarta City Health Office.
Stage 1. Carrier screening
The study team invites food handlers working in MBG kitchens in Surakarta. About 100 food handlers will join after written informed consent. The team collects basic data with a questionnaire. Each participant gives a venous blood sample for the Widal test. A Vi or O/H titer above 1/160 is counted as a suspected carrier. Suspected carriers give a rectal swab. The swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. A participant with a positive culture is a confirmed carrier. Participants with a negative Widal test or a negative culture end their study participation after stage 1. All confirmed carriers are referred for care and are offered entry into stage 2.
Stage 2. Randomized controlled trial
Confirmed carriers who meet the eligibility criteria are randomly assigned in a 1:1 ratio to one of two arms. The trial is double-blind. Participants and investigators do not know the group assignment. Curcumin capsules and placebo capsules look the same.
Arm 1 receives ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days.
Arm 2 receives ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days.
The team checks adherence during treatment with pill counts and a daily log. Adherence above 90% is the target. The team also records adverse events. A repeat rectal swab culture is done 30 days after the last dose.
Outcomes
The primary outcome is eradication. Eradication means no growth of Salmonella Typhi in the rectal swab culture 30 days after treatment ends. Secondary outcomes are adherence, adverse events, and the prevalence of carriage among screened food handlers.
Statistical analysis
The proportion of participants with eradication is compared between the two arms. The chi-square test or Fisher's exact test is used. A p value below 0.05 is considered significant.
Ethics
The protocol (version 2) was approved by the Research Ethics Committee of Universitas Sebelas Maret Hospital (No. 196.1/UN27.46/TA.04.19/KEP/EC/2026). The approval follows the 7 WHO 2011 standards and the 2016 CIOMS guidelines. All participants give written informed consent.
Funding
This study is funded by Universitas Sebelas Maret through the Penelitian Fundamental B (PFB-UNS) research grant, 2026 (registration number 00070574055812026).
76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.
This study's planned enrollment of 100 is below the median of 147 across 65 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →Universitas Sebelas Maret is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
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Additional Inclusion Criteria (stage 2, randomized trial):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Culture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus curcumin extract 1,000 mg per day by mouth for 28 days.
Dietary Supplement: Curcumin extract · Drug: Ciprofloxacin
Culture-confirmed typhoid carriers take ciprofloxacin 500 mg by mouth twice daily plus placebo capsules (amylum) for 28 days. The placebo capsules look the same as the curcumin capsules.
Drug: Ciprofloxacin · Other: Placebo
Curcumin extract capsules, 1,000 mg per day by mouth for 28 days. Given together with ciprofloxacin.
Also known as: Curcuma longa extract, Turmeric extract
Ciprofloxacin 500 mg tablet by mouth twice daily for 28 days. Both arms receive ciprofloxacin.
Capsules filled with amylum (starch). They look the same as the curcumin capsules. Taken on the same schedule for 28 days.
Proportion of participants with negative Salmonella Typhi culture (eradication)
A rectal swab is cultured on Salmonella Shigella Agar. Suspected colonies are confirmed with IMViC biochemical tests. Eradication means no growth of Salmonella Typhi. The proportion is compared between the two arms.
Time frame: 30 days after the end of the 28-day treatment
Treatment adherence
Percentage of prescribed capsules taken. Measured by pill count and a daily intake log. Adherence above 90% is counted as good adherence.
Time frame: Day 1 to day 28 of treatment
Number of participants with adverse events
Adverse events are recorded at each monitoring visit. They include gastrointestinal complaints, skin reactions, and any other event reported by the participant or found by the investigator.
Time frame: From the first dose to 30 days after the end of the 28-day treatment
Prevalence of typhoid carriage among screened food handlers
Number of food handlers with culture-confirmed Salmonella Typhi carriage divided by the number of food handlers screened, expressed as a percentage.
Time frame: At screening (stage 1, before randomization)
Positive predictive value of the Widal test for culture-confirmed carriage
Proportion of participants with a Vi or O/H Widal titer above 1/160 who have a positive rectal swab culture for Salmonella Typhi.
Time frame: At screening (stage 1, before randomization)
Fluoroquinolone susceptibility of Salmonella Typhi isolates
Number of isolates that are susceptible, intermediate, or resistant to ciprofloxacin and other fluoroquinolones on antimicrobial susceptibility testing.
Time frame: At screening (stage 1, before randomization)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Turmeric extract
Universitas Sebelas Maret